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Heart Rate Variability Biofeedback Training in Psychogenic Disorders (ECoDys)

Primary Purpose

Psychogenic Dystonia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Heart rate variability biofeedback training (Symbiocenter)

psychoeducation session

About this trial

This is an interventional supportive care trial for Psychogenic Dystonia focused on measuring Cervical dystonia, Psychogenic disorder, Heart Rate Variability, Functional neurosurgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age 18 to 75
Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"], selected by the multidisciplinary team after a phase 1 assessment.
Patient benefiting from a social security scheme

Exclusion criteria:

Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2)
Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30),
Absence foreseeable at least 30% of the sessions,
Lack of informed consent.
Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women
Major protected by law or patient under guardianship or curatorship
Participation in other ongoing research

Sites / Locations

Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HRV biofeedback training

control

Arm Description

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. This group of patients will also benefit from the HRV biofeedback training.

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist.

Outcomes

Primary Outcome Measures

Variability of the cervical dystonia at 6 months

Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)

Secondary Outcome Measures

Variability of the cervical dystonia at 3 months

Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)

Quality of life assessment in cervical dystonia at 3 months

Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale

Quality of life assessment in cervical dystonia at 6 months

Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale

Quality of life assessment at 3 months

Measured by SF-36 scale

Quality of life assessment at 6 months

Measured by SF-36 scale

Assessment of the severity of depression at 3 month

Measured by Beck Depression Inventory (BDI-II) scale

Assessment of the severity of depression at 6 month

Measured by the Beck Depression Inventory (BDI-II) scale

Assessment of the anxiety at 3 month

Measured by the State-Trait Anxiety Inventory (STAI A & B) scale

Assessment of the anxiety at 6 month

Measured by the State-Trait Anxiety Inventory (STAI A & B) scale

satisfaction with the care

satisfaction's VAS

medical nomadism index

The index of "presumed nomadism" is the difference between the number of different doctors consulted and the number of different specialties of these same doctors. Any patient whose index is ≥ 3 over a period of 6 months is presumed nomadic.

Full Information

NCT ID

NCT04777825

First Posted

September 8, 2020

Last Updated

May 6, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT04777825

Brief Title

Heart Rate Variability Biofeedback Training in Psychogenic Disorders

Acronym

ECoDys

Official Title

Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ". Patients of the respiratory coherence group will receive HRV biofeedback training for 12 sessions during a 6 months-period. The hypothesis is that this kind of physiological noninvasive therapy increasing coherence respiratory, will reduce pain and patient's complain about their psychogenic abnormal head posture. Improvement of anxiety, depression and quality of life are expected.

Detailed Description

Patients presenting with an isolated abnormal head posture, first diagnosed as cervical dystonia, demonstrated in fact, after neurological screening, to be of psychogenic origine. These patients are not candidate for functional surgery and, furthermore, usually refuse psychotherapy leading them to medical nomadism. This study proposes to evaluate the efficacy of an innovative intervention program based on Heart Rate Variability (HRV) biofeedback that promotes self-regulatory skills in dysfunctional movement disorders (DMD) patients in order to improve their condition and symptomatology. Heart rate is under the control of efferent sympathetic and vagal activities directed to the sinus node, which are modulated by central brain stem (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial pressure and respiratory movements). Spectral analysis of HRV is a reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the sinus node. Several biofeedback protocols and assistive electronic technologies, such as proposed by SymbioCenter©, exist to enhance increase HRV and synchronize respiration with the heart rhythm. HRV biofeedback training appears to be an opportunity in the patient's management in order of preventing medical overconsuming. It is offering a safe and non-pharmacological alternative approach managed by a multidisciplinary team in a functional neurosurgery unit. It is expected that developing respiratory coherence in these patients will improve their painful symptomatology.

6. Conditions and Keywords

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

Psychogenic Dystonia

Keywords

Cervical dystonia, Psychogenic disorder, Heart Rate Variability, Functional neurosurgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HRV biofeedback training

Arm Type

Experimental

Arm Description

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. This group of patients will also benefit from the HRV biofeedback training.

Arm Title

control

Arm Type

Other

Arm Description

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist.

Intervention Type

Other

Intervention Name(s)

Heart rate variability biofeedback training (Symbiocenter)

Intervention Description

12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training

Intervention Type

Other

Intervention Name(s)

psychoeducation session

Intervention Description

Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).

Primary Outcome Measure Information:

Title

Variability of the cervical dystonia at 6 months

Description

Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Variability of the cervical dystonia at 3 months

Description

Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)

Time Frame

3 months

Title

Quality of life assessment in cervical dystonia at 3 months

Description

Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale

Time Frame

3 months

Title

Quality of life assessment in cervical dystonia at 6 months

Description

Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale

Time Frame

6 months

Title

Quality of life assessment at 3 months

Description

Measured by SF-36 scale

Time Frame

3 months

Title

Quality of life assessment at 6 months

Description

Measured by SF-36 scale

Time Frame

6 months

Title

Assessment of the severity of depression at 3 month

Description

Measured by Beck Depression Inventory (BDI-II) scale

Time Frame

3 months

Title

Assessment of the severity of depression at 6 month

Description

Measured by the Beck Depression Inventory (BDI-II) scale

Time Frame

6 months

Title

Assessment of the anxiety at 3 month

Description

Measured by the State-Trait Anxiety Inventory (STAI A & B) scale

Time Frame

3 months

Title

Assessment of the anxiety at 6 month

Description

Measured by the State-Trait Anxiety Inventory (STAI A & B) scale

Time Frame

6 months

Title

satisfaction with the care

Description

satisfaction's VAS

Time Frame

6 months

Title

medical nomadism index

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age 18 to 75 Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"], selected by the multidisciplinary team after a phase 1 assessment. Patient benefiting from a social security scheme Exclusion criteria: Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2) Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30), Absence foreseeable at least 30% of the sessions, Lack of informed consent. Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women Major protected by law or patient under guardianship or curatorship Participation in other ongoing research

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emily SANREY, MSc

Phone

467337445

Ext

+33

e-sanrey@chu-montpellier.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Valérie GIL, CTA

Phone

467337464

Ext

+33

v-gil@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe COUBES, MD, PhD

Organizational Affiliation

Montpellier University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montpellier University Hospital

City

Montpellier

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily SANREY, MSc

Phone

467337445

Ext

+33

e-sanrey@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Valérie GIL, CTA

Phone

467337464

Ext

+33

v-gil@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Heart Rate Variability Biofeedback Training in Psychogenic Disorders

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