search
Back to results

Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients (CONVERSTIM)

Primary Purpose

Conversion Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurostimulation with non-implanted electrodes
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conversion Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent.
  • The patient is at least (≥) 18 years old and 65 years old at the most (≤). The risk of an increased frequency of somatic comorbidity, drug co-prescription, and cognitive impairment prompts us to limit recruitment to age 65 in this study.
  • The patient is hospitalized or followed in consultation.
  • Patient is available for a follow-up of 6 months.
  • With current DSM-5 criteria for conversion disorder during more than 10 days, motor type (i.e. with paralysis or motor weakness) and initial EDSS score ≥ 3.

Exclusion Criteria:

  • The patient is participating in another interventional trial.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient.
  • The patient is pregnant or breastfeeding.
  • Specialized neurological clinical examination and the performing of brain and medullary MRI reveal an organic neurological involvement.
  • Current episode of mania, hypomania, diagnosis of substance abuse/dependence (excluding smoking), diagnosis of schizophrenia over lifetime, severe neurological pathology (epilepsy, stroke, brain tumor).
  • Patient with a contraindication to MRI (for patients enrolled in Nîmes).
  • Acute eczema at the electrodes loci.

Sites / Locations

  • Centre Hospitalier UniversitaireRecruiting
  • Hôpital La Colombière Service de Psychiatrie
  • CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie
  • Hôpital Lapeyronie
  • Hospices Civils de Lyon Hôpital Edouard Herriot
  • CHU de Nantes
  • Clinique St Exupery
  • Hôpital Saint-Antoine Service de Psychiatrie APHP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

"active tDCS" group

"sham tDCS" group

Arm Description

Patients will benefit from a series of 10 double-blind effective tDCS stimulation sessions over a period of 5 days (Monday to Friday): each stimulation series will include two daily stimulation sessions spaced 3 hours apart for 5 days.

Patients will benefit from a series of 10 double-blind placebo tDCS stimulation sessions over a period of 5 days (Monday to Friday): each stimulation series will include two daily stimulation sessions spaced 3 hours apart for 5 days.

Outcomes

Primary Outcome Measures

Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder 3 months after the intervention.
Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder at 3 months after the stimulation procedure with the EDSS (Expanded Disability Status Scale). The Expanded Disability Status Scale is a rating scale of disability divided into eight systems or functional parameters, four major: pyramidal function, cerebellar function, sensory function and brainstem function; four minor: sphincters,vision, mind and others. An encrypted score of increasing severities (0 to 6 or 7) is given to each functional parameter. The overall score of the scale is measured on a scale of 20 levels (0 to 10 per half-point). Up to level 3.5, the score obtained in each functional parameter and the number of affected functional parameters automaticaly determines the EDSS score. From 4 to 7, the definition of each level is also given by the inability to walk (ability to walk without stopping - need for assistance).

Secondary Outcome Measures

Evaluation of the efficacy on motor symptoms at D7 with NIHSS
Evaluation of the efficacy on motor symptoms at Day 7 with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Evaluation of the persistence of efficacy on motor symptoms at 1 month
Evaluation of the efficacy on motor symptoms at 1 month with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Evaluation of the persistence of efficacy on motor symptoms at 3 months
Evaluation of the efficacy on motor symptoms at 3 months with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Evaluation of the persistence of efficacy on motor symptoms at 6 months
Evaluation of the efficacy on motor symptoms at 6 months with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Evaluation of the efficacy on motor disability with EDSS score at D7.
Evaluation of the efficacy of the intervention on motor symptoms at D7 using the Expanded Disability Status Scale (EDSS). The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
Evaluation of the persistence of efficacy on motor disability with EDSS at 1 month
Evaluation of the persistence of efficacy of the intervention using the Expanded Disability Status Scale (EDSS) at 1 month. The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
Evaluation of the persistence of efficacy on motor disability with EDSS at 6 months.
Evaluation of the persistence of efficacy of the intervention on motor disability using the Expanded Disability Status Scale (EDSS) at 6 months.The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
WHO score at D7
Evaluation of the efficacy of the intervention on motor disability with WHO Performance Status at Day 7. The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
WHO score at 1 month
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO score at 1 month.The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
WHO score at 3 months
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO at 3 months.The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
WHO score at 6 months
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO at 3 months. The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
CGI (Clinical Global Impression) scores at Day 7
Evaluation of the efficacy on motor disability with Clinical Global Impression score at Day 7. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
CGI (Clinical Global Impression) score at 3 months
Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
CGI (Clinical Global Impression) score at 6 months
Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Modified Rankin (mRS) score at D7
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at D7 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Modified Rankin (mRS) score at 1 month
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Modified Rankin (mRS) score at 3 months
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month.The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Modified Rankin (mRS) score at 6 months
Evaluation of the efficacy on motor disability with modified Rankin (mRS) score at 6 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Evaluation of disability related to abnormal movements - CGI at D7.
Evaluate the efficacy on disability related to abnormal movements with Clinical Global Impression scores at Day 7.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Evaluation of disability related to abnormal movements - CGI at 1 month.
Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 1 month.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Evaluation of disability related to abnormal movements - CGI at 3 months.
Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Evaluation of disability related to abnormal movements - CGI at 6 months.
Evaluation of the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at D7
Evaluation of the efficacy of the intervention on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at D7. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 1 month
Evaluation of the persistence of efficacy on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at 1 month. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 3 months .
Evaluation of the persistence of efficacy on depression and anxiety level assessed with the Hospital Anxiety and Depression Scale (HADS) at D7 and persistence at 3 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.
Evaluation of the persistence of efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at D7
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at D7.
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 1 month
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 1 month.
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 3 months
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 3 months.
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 6 months
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 6 months.
Tolerance to tDCS stimulation D2 - D6 Brunoni
Evaluate the tolerance to tDCS stimulation sessions from D2 to D6 with Brunoni's questionnaire.To monitor and evaluate the potential adverse effects of tDCS in patients receiving this treatment, Brunoni et al. (2011) proposed a structured questionnaire. The patient answers questions regarding symptoms or side-effects on different parts of the body and their severity ranges from 1 - 4 (1 = absent, 2 = mild, 3 = moderate, 4 = severe). The probability of these symptoms or side-effects being related to the tDCS stimulation treatment is also noted from 1 - 5 ( 1 = none, 2 = remote, 3 = possible, 4 = probable, 5 = definite).
Correlation between putative modification of motor symptoms and changes in activity (rest / motor imagery task) of the PFDLC monitored by brain fMRI at Day 0 and Day 7.
Evaluation of the correlation between putative modification of motor symptoms and changes in activity (at rest or during a motor imagery task) of the PFDLC monitored by functional brain MRI at day 0 and day 7, i.e. search for early response markers to the treatment.
Evaluation of Dissociative Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD at day 7
Evaluation of Dissociative Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluation of Dissociative Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluation of Dissociative Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluate the evolution of dissociation Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluate the evolution of dissociation Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluate the evolution of dissociation Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluate the evolution of dissociation Experiences Scale
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Score at the CGI questionnaire
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Score at the CGI questionnaire
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Score at the CGI questionnaire
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Score at the CGI questionnaire

Full Information

First Posted
September 18, 2019
Last Updated
June 22, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT04097184
Brief Title
Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients
Acronym
CONVERSTIM
Official Title
Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date. The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms. However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced. Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.
Detailed Description
Conversion disorder, also called "functional neurological disorder" (DSM-5), refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments (Carson et al. 2000) and the symptoms persist in 35% of patients after 12 years of evolution (Stone et al. 2003). Despite a poor prognosis, no treatments have been validated to date. The development of non-invasive brain stimulation techniques has allowed the creation of focused treatments on dysfunctional brain regions associated with motor conversion disorder. A hypoactivation of prefrontal dorso-lateral cortex (PFDLC) underlies the course of functional motor symptoms (Spence et al. 2000); (Voon et al.2011); (Conejero et al. 2017). Results of the HYCORE study that the investigators conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms. However, in the majority of repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted (Pollak et al. 2014) and the clinical improvement was related to self-suggestion induced by the motor response produced. Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conversion Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective multicentre controlled randomized, double-blind, two-arm study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will then be randomized and assigned to one of the 2 groups: the first group will receive a series of 10 effective stimulation sessions (experimental group "active tDCS") and the second group will receive a series of 10 placebo stimulation sessions (control group "sham tDCS").
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"active tDCS" group
Arm Type
Active Comparator
Arm Description
Patients will benefit from a series of 10 double-blind effective tDCS stimulation sessions over a period of 5 days (Monday to Friday): each stimulation series will include two daily stimulation sessions spaced 3 hours apart for 5 days.
Arm Title
"sham tDCS" group
Arm Type
Sham Comparator
Arm Description
Patients will benefit from a series of 10 double-blind placebo tDCS stimulation sessions over a period of 5 days (Monday to Friday): each stimulation series will include two daily stimulation sessions spaced 3 hours apart for 5 days.
Intervention Type
Device
Intervention Name(s)
Neurostimulation with non-implanted electrodes
Intervention Description
Neurostimulation with non-implanted electrodes
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder 3 months after the intervention.
Description
Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder at 3 months after the stimulation procedure with the EDSS (Expanded Disability Status Scale). The Expanded Disability Status Scale is a rating scale of disability divided into eight systems or functional parameters, four major: pyramidal function, cerebellar function, sensory function and brainstem function; four minor: sphincters,vision, mind and others. An encrypted score of increasing severities (0 to 6 or 7) is given to each functional parameter. The overall score of the scale is measured on a scale of 20 levels (0 to 10 per half-point). Up to level 3.5, the score obtained in each functional parameter and the number of affected functional parameters automaticaly determines the EDSS score. From 4 to 7, the definition of each level is also given by the inability to walk (ability to walk without stopping - need for assistance).
Time Frame
3 months after the intervention
Secondary Outcome Measure Information:
Title
Evaluation of the efficacy on motor symptoms at D7 with NIHSS
Description
Evaluation of the efficacy on motor symptoms at Day 7 with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Time Frame
7 days after the intervention
Title
Evaluation of the persistence of efficacy on motor symptoms at 1 month
Description
Evaluation of the efficacy on motor symptoms at 1 month with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Time Frame
1 month after the intervention
Title
Evaluation of the persistence of efficacy on motor symptoms at 3 months
Description
Evaluation of the efficacy on motor symptoms at 3 months with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Time Frame
3 months after the intervention
Title
Evaluation of the persistence of efficacy on motor symptoms at 6 months
Description
Evaluation of the efficacy on motor symptoms at 6 months with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
Time Frame
6 months after the intervention
Title
Evaluation of the efficacy on motor disability with EDSS score at D7.
Description
Evaluation of the efficacy of the intervention on motor symptoms at D7 using the Expanded Disability Status Scale (EDSS). The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
Time Frame
7 days after the intervention
Title
Evaluation of the persistence of efficacy on motor disability with EDSS at 1 month
Description
Evaluation of the persistence of efficacy of the intervention using the Expanded Disability Status Scale (EDSS) at 1 month. The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
Time Frame
1 month after the intervention
Title
Evaluation of the persistence of efficacy on motor disability with EDSS at 6 months.
Description
Evaluation of the persistence of efficacy of the intervention on motor disability using the Expanded Disability Status Scale (EDSS) at 6 months.The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
Time Frame
6 month after the intervention
Title
WHO score at D7
Description
Evaluation of the efficacy of the intervention on motor disability with WHO Performance Status at Day 7. The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
Time Frame
7 days after the intervention
Title
WHO score at 1 month
Description
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO score at 1 month.The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
Time Frame
1 month after the intervention
Title
WHO score at 3 months
Description
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO at 3 months.The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
Time Frame
3 months after the intervention
Title
WHO score at 6 months
Description
Evaluation of the persistence of efficacy of the intervention on motor disability with WHO at 3 months. The WHO (World Health Organization) Performance Status is a 5-point scale and is the simplest and fastest indicator to judge the state of autonomy of a person: 0 Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Dead
Time Frame
3 months after the intervention
Title
CGI (Clinical Global Impression) scores at Day 7
Description
Evaluation of the efficacy on motor disability with Clinical Global Impression score at Day 7. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
7 days after the intervention
Title
CGI (Clinical Global Impression) score at 3 months
Description
Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
3 months after the intervention
Title
CGI (Clinical Global Impression) score at 6 months
Description
Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
6 months after the intervention
Title
Modified Rankin (mRS) score at D7
Description
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at D7 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Time Frame
7 days after the intervention
Title
Modified Rankin (mRS) score at 1 month
Description
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Time Frame
1 month after the intervention
Title
Modified Rankin (mRS) score at 3 months
Description
Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month.The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Time Frame
3 months after the intervention
Title
Modified Rankin (mRS) score at 6 months
Description
Evaluation of the efficacy on motor disability with modified Rankin (mRS) score at 6 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
Time Frame
6 months after the intervention
Title
Evaluation of disability related to abnormal movements - CGI at D7.
Description
Evaluate the efficacy on disability related to abnormal movements with Clinical Global Impression scores at Day 7.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
7 days after the intervention
Title
Evaluation of disability related to abnormal movements - CGI at 1 month.
Description
Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 1 month.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
1 month after the intervention
Title
Evaluation of disability related to abnormal movements - CGI at 3 months.
Description
Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
3 months after the intervention
Title
Evaluation of disability related to abnormal movements - CGI at 6 months.
Description
Evaluation of the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
Time Frame
6 months after the intervention
Title
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at D7
Description
Evaluation of the efficacy of the intervention on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at D7. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Time Frame
7 days after the intervention
Title
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 1 month
Description
Evaluation of the persistence of efficacy on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at 1 month. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Time Frame
1 month after the intervention
Title
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 3 months .
Description
Evaluation of the persistence of efficacy on depression and anxiety level assessed with the Hospital Anxiety and Depression Scale (HADS) at D7 and persistence at 3 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Time Frame
3 months after the intervention
Title
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.
Description
Evaluation of the persistence of efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows: 0-7: normal 8-10: average 11-14: moderate 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
Time Frame
6 months after the intervention
Title
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at D7
Description
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at D7.
Time Frame
7 days after the intervention
Title
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 1 month
Description
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 1 month.
Time Frame
1 month after the intervention
Title
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 3 months
Description
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 3 months.
Time Frame
3 months after the intervention
Title
Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 6 months
Description
Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 6 months.
Time Frame
6 months after the intervention
Title
Tolerance to tDCS stimulation D2 - D6 Brunoni
Description
Evaluate the tolerance to tDCS stimulation sessions from D2 to D6 with Brunoni's questionnaire.To monitor and evaluate the potential adverse effects of tDCS in patients receiving this treatment, Brunoni et al. (2011) proposed a structured questionnaire. The patient answers questions regarding symptoms or side-effects on different parts of the body and their severity ranges from 1 - 4 (1 = absent, 2 = mild, 3 = moderate, 4 = severe). The probability of these symptoms or side-effects being related to the tDCS stimulation treatment is also noted from 1 - 5 ( 1 = none, 2 = remote, 3 = possible, 4 = probable, 5 = definite).
Time Frame
From 2 days to 6 days after the intervention
Title
Correlation between putative modification of motor symptoms and changes in activity (rest / motor imagery task) of the PFDLC monitored by brain fMRI at Day 0 and Day 7.
Description
Evaluation of the correlation between putative modification of motor symptoms and changes in activity (at rest or during a motor imagery task) of the PFDLC monitored by functional brain MRI at day 0 and day 7, i.e. search for early response markers to the treatment.
Time Frame
Day 0 and Day 7
Title
Evaluation of Dissociative Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD at day 7
Time Frame
7 days after the intervention
Title
Evaluation of Dissociative Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
1 month after the intervention
Title
Evaluation of Dissociative Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
3 month after the intervention
Title
Evaluation of Dissociative Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
6 month after the intervention
Title
Evaluate the evolution of dissociation Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
7 days after the intervention
Title
Evaluate the evolution of dissociation Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
1 month after the intervention
Title
Evaluate the evolution of dissociation Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
3 month after the intervention
Title
Evaluate the evolution of dissociation Experiences Scale
Description
Evaluate the influence of the initial level of psychic dissociation assessed with the DES scale at D0 on the efficacy of tDCS treatment on the motor's symptoms of CD
Time Frame
6 month after the intervention
Title
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Description
Score at the CGI questionnaire
Time Frame
7 days after the intervention
Title
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Description
Score at the CGI questionnaire
Time Frame
1 month after the intervention
Title
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Description
Score at the CGI questionnaire
Time Frame
3 month after the intervention
Title
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.
Description
Score at the CGI questionnaire
Time Frame
6 month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given his/her informed and signed consent. The patient is at least (≥) 18 years old and 65 years old at the most (≤). The risk of an increased frequency of somatic comorbidity, drug co-prescription, and cognitive impairment prompts us to limit recruitment to age 65 in this study. The patient is hospitalized or followed in consultation. Patient is available for a follow-up of 6 months. With current DSM-5 criteria for conversion disorder during more than 10 days, motor type (i.e. with paralysis or motor weakness) and initial EDSS score ≥ 3 or initial WHO Score is ≥ 2 Exclusion Criteria: The patient is participating in another interventional trial. The patient refuses to sign the consent. It is impossible to correctly inform the patient. The patient is pregnant or breastfeeding. Specialized neurological clinical examination and the performing of brain and medullary MRI reveal an organic neurological involvement. Current episode of mania, hypomania, diagnosis of substance abuse/dependence (excluding smoking), diagnosis of schizophrenia over lifetime, severe neurological pathology (epilepsy, stroke, brain tumor). Patient with a contraindication to MRI (for patients enrolled in Nîmes). Acute eczema at the electrodes loci.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ismael CONEJERO, Dr.
Phone
07 70 21 62 38
Email
ismael.conejero@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismael CONEJERO, Dr.
Organizational Affiliation
CHU de Nîmes (Nîmes University Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Phone
04 66 68 30 52
Email
anissa.megzari@CHU-nimes.fr
First Name & Middle Initial & Last Name & Degree
Ismael CONEJERO, Dr
First Name & Middle Initial & Last Name & Degree
Mocrane ABBAR, Dr
First Name & Middle Initial & Last Name & Degree
Jorge LOPEZ CASTROMAN, Pr.
First Name & Middle Initial & Last Name & Degree
Eric THOUVENOT, Pr.
First Name & Middle Initial & Last Name & Degree
Fabricio PEREIRA, M.
Facility Name
Hôpital La Colombière Service de Psychiatrie
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme ATTAL, Dr.
Phone
04 67 33 67 33
Email
j-attal@chu-montpellier.fr
Facility Name
CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline ARQUIZAN, Dr
Phone
04 67 33 74 13
Email
c-arquizan@chu-montpellier.fr
Facility Name
Hôpital Lapeyronie
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie OLIÉ, Dr
Phone
04 67 33 85 81
Email
e-olie@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Philippe COURTET
Facility Name
Hospices Civils de Lyon Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel POULET, Pr.
Phone
04 72 11 00 09
Email
emmanuel.poulet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Mohamed SAOUD, Pr.
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNE SAUVAGET, PHPD
Phone
02 40 08 47 95
Email
Anne.sauvaget@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
PHILIPPE DAMIER, PHPD
Facility Name
Clinique St Exupery
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARLE-TOULEMONDE Guilhem
Phone
05 32 18 32 39
Email
guilhemcarle@gmail.com
Facility Name
Hôpital Saint-Antoine Service de Psychiatrie APHP
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane MOUCHABAC, Dr.
Phone
01 49 28 27 69
Email
stephane.mouchabac@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients

We'll reach out to this number within 24 hrs