Back to resultsIntegrated Treatment in FND (Functional Neurological Disorders) (FND)
Primary Purpose
Functional Neurological Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Psychotherapy
Physiotherapy
Non-Invasive Brain Stimulation (NIBS)
Sponsored by
About this trial
This is an interventional treatment trial for Functional Neurological Disorder focused on measuring FND, physiotherapy, psychotherapy, non-invasive brain stimulation
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written informed consent
- Diagnosis of Functional Neurological Disorder of movement clinically established according to DSM-5 criteria
- Age between 18 and 65 years (inclusive)
- Ability to participate in the study protocol
Exclusion Criteria:
- Inability to provide written informed consent
- Pregnant women
- In case of use of non-invasive brain stimulation techniques: the subjects must not present any of the contraindications specific to this method (for further specifications see the "Methods" and the "Stimulation Evaluation Questionnaire" attached to this proposal)
- Presence of unstable clinical conditions or infections
- In the case of the use of non-invasive brain stimulation techniques: concomitant use of drugs that can alter the transmission and synaptic plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, Selective Serotonin Reuptake Inhibitors (SSRI), botulinum toxin)
- Inability to support physiotherapy or psychotherapy sessions
Sites / Locations
- I.R.C.C.S. NEUROMED Istituto Neurologico MediterraneoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with FND
Arm Description
Diagnosis of Functional Neurological Disorder of movement clinically established according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
Outcomes
Primary Outcome Measures
Changes and improvement in clinical condition
the Clinical global impression scale will be used. It is a brief 3-item observer-rated scale that assess severity of illness with assignable scores ranging from 0 to 7 (at every time time point), the global improvement with assignable scores ranging from 0 to 7 (from the second time point), and the efficacy index with assignable scores ranging from 1 to 16 (relationship between therapeutic efficacy and undesirable effects). Higher scores on these scales mean a worse outcome.
Changes in quality of life
The Short Form Health Survey 36 (SF-36) will be used. It is a generic, multidimensional tool, consisting of 36 questions that can be divided into 8 scales (Physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, emotional well-being, social activities, pain, general health perception) expressed as percentage values 0-100%. Higher scores on these scales mean a better quality of life.
Changes in executive functions and attention - step 1
Will be used the Symbol Digit Modalities Test, which measures the processing speed, in the oral version of this test (Nocentini et al., 2006). The assignable performance's scores ranging from 0 to 110. The cut-off for normality in italian population for this oral version was 34.2. Higher scores on these scales mean a better processing speed.
Changes in executive functions and attention - step 2
Stroop test
Changes in neuroplasticity
Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. Any increase or decrease in amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, long term potentiation (LTP) or depression (LTD).
Evaluation of genetic polymorphisms
A blood sample (10 ml) will be collected to investigate whether genetic polymorphisms related to patients' neuronal plasticity can be related to the response to the protocol.
Secondary Outcome Measures
Changes in behavioral aspects - step 1
State-Trait Anxiety Inventory-Form Y (STAI-Y). The STAI-Y is a self-report questionnaire consisting of two 20-item scales providing separate measures of state and trait anxiety, on a 4-point Likert scale, with scores ranges from 20 to 80, with higher scores indicating more severe outcome.
Changes in behavioral aspects - step 2
Beck Depression Inventory - Second Edition (BDI-II). BDI-II is a self-report questionnaire consisting of 21-item self-report scale designed to measure the severity of depressive symptoms, on a 4-point Likert scale, with scores ranges from 0 to 63, with higher scores indicating more severe outcome.
Changes in behavioral aspects - step 3
Toronto Alexithymia Scale (TAS-20). TAS-20 is a self-report questionnaire scale designed to measure alexithymia, on a 5-point Likert scale, with scores ranges from 20 to 100, with higher scores indicating more severe outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04310670
Brief Title
Integrated Treatment in FND (Functional Neurological Disorders)
Acronym
FND
Official Title
Role of Integrated Treatment in Patients With Functional Neurological Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuromed IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project will investigate the effectiveness of patient-centered integrated treatment.
The correlations between physiotherapy indices, non-invasive brain stimulation, connectivity and psychological support will be analyzed.
Detailed Description
At the time of recruitment (T0) a multidimensional evaluation will be performed consisting of clinical, neuropsychological, neurophysiological, MRI, data obtained from peripheral blood sampling (10ml). After completing the program (12 weeks), the effect will be assessed according to objectives (T1). The study will also include a follow-up evaluation after 6 months (T2) and 12 months (T3) from the beginning of the treatment to evaluate the persistence of the beneficial effects after some time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Disorder
Keywords
FND, physiotherapy, psychotherapy, non-invasive brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with FND
Arm Type
Experimental
Arm Description
Diagnosis of Functional Neurological Disorder of movement clinically established according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
The patient will be treated according to Lacanian psychoanalytic ethics, which allows to adequately respond to the patient's request for healing but who at the same time does not ignore the progress of scientific research in the neurological field
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy treatment will be articulated through the use of techniques designed to qualify the functionality of the subject divided by symptom: weakness, dystonic attitudes of the limbs, walking disorders, tremor.
Intervention Type
Other
Intervention Name(s)
Non-Invasive Brain Stimulation (NIBS)
Intervention Description
Diversified transcranial electrical maneuver protocols with an "on-line" or "off-line" approach may be applied for therapeutic purposes. This will include: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), random noise stimulation (tRNS).
Primary Outcome Measure Information:
Title
Changes and improvement in clinical condition
Description
the Clinical global impression scale will be used. It is a brief 3-item observer-rated scale that assess severity of illness with assignable scores ranging from 0 to 7 (at every time time point), the global improvement with assignable scores ranging from 0 to 7 (from the second time point), and the efficacy index with assignable scores ranging from 1 to 16 (relationship between therapeutic efficacy and undesirable effects). Higher scores on these scales mean a worse outcome.
Time Frame
1-12 months
Title
Changes in quality of life
Description
The Short Form Health Survey 36 (SF-36) will be used. It is a generic, multidimensional tool, consisting of 36 questions that can be divided into 8 scales (Physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, emotional well-being, social activities, pain, general health perception) expressed as percentage values 0-100%. Higher scores on these scales mean a better quality of life.
Time Frame
1-12 months
Title
Changes in executive functions and attention - step 1
Description
Will be used the Symbol Digit Modalities Test, which measures the processing speed, in the oral version of this test (Nocentini et al., 2006). The assignable performance's scores ranging from 0 to 110. The cut-off for normality in italian population for this oral version was 34.2. Higher scores on these scales mean a better processing speed.
Time Frame
1-12 months
Title
Changes in executive functions and attention - step 2
Description
Stroop test
Time Frame
1-12 months
Title
Changes in neuroplasticity
Description
Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. Any increase or decrease in amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, long term potentiation (LTP) or depression (LTD).
Time Frame
1-12 months
Title
Evaluation of genetic polymorphisms
Description
A blood sample (10 ml) will be collected to investigate whether genetic polymorphisms related to patients' neuronal plasticity can be related to the response to the protocol.
Time Frame
1-12 months
Secondary Outcome Measure Information:
Title
Changes in behavioral aspects - step 1
Description
State-Trait Anxiety Inventory-Form Y (STAI-Y). The STAI-Y is a self-report questionnaire consisting of two 20-item scales providing separate measures of state and trait anxiety, on a 4-point Likert scale, with scores ranges from 20 to 80, with higher scores indicating more severe outcome.
Time Frame
1-12 months
Title
Changes in behavioral aspects - step 2
Description
Beck Depression Inventory - Second Edition (BDI-II). BDI-II is a self-report questionnaire consisting of 21-item self-report scale designed to measure the severity of depressive symptoms, on a 4-point Likert scale, with scores ranges from 0 to 63, with higher scores indicating more severe outcome.
Time Frame
1-12 months
Title
Changes in behavioral aspects - step 3
Description
Toronto Alexithymia Scale (TAS-20). TAS-20 is a self-report questionnaire scale designed to measure alexithymia, on a 5-point Likert scale, with scores ranges from 20 to 100, with higher scores indicating more severe outcome.
Time Frame
1-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability to provide written informed consent
Diagnosis of Functional Neurological Disorder of movement clinically established according to DSM-5 criteria
Age between 18 and 65 years (inclusive)
Ability to participate in the study protocol
Exclusion Criteria:
Inability to provide written informed consent
Pregnant women
In case of use of non-invasive brain stimulation techniques: the subjects must not present any of the contraindications specific to this method (for further specifications see the "Methods" and the "Stimulation Evaluation Questionnaire" attached to this proposal)
Presence of unstable clinical conditions or infections
In the case of the use of non-invasive brain stimulation techniques: concomitant use of drugs that can alter the transmission and synaptic plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, Selective Serotonin Reuptake Inhibitors (SSRI), botulinum toxin)
Inability to support physiotherapy or psychotherapy sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Centonze, MD
Phone
+390865929250
Email
ambulatoriodnf.neuromed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Stampanoni Bassi, MD
Phone
+39 3460181370
Email
mario_sb@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Centonze
Organizational Affiliation
IRCCS Neuromed
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
31606137
Citation
Galli S, Bereau M, Magnin E, Moulin T, Aybek S. Functional movement disorders. Rev Neurol (Paris). 2020 May;176(4):244-251. doi: 10.1016/j.neurol.2019.08.007. Epub 2019 Oct 9.
Results Reference
result
PubMed Identifier
29606068
Citation
O'Neal MA, Baslet G. Treatment for Patients With a Functional Neurological Disorder (Conversion Disorder): An Integrated Approach. Am J Psychiatry. 2018 Apr 1;175(4):307-314. doi: 10.1176/appi.ajp.2017.17040450. No abstract available.
Results Reference
result
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Integrated Treatment in FND (Functional Neurological Disorders)
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