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

Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay

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.

Study Overview

• Status: Recruiting
• Conditions: Conversion Disorder
• Intervention / Treatment: Device: Neurostimulation with non-implanted electrodes

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismael CONEJERO, Dr.; Phone Number: 07 70 21 62 38; Email: ismael.conejero@gmail.com

Study Locations

• France
  • Lyon, France, 69003
    • Not yet recruiting
    • Hospices Civils de Lyon Hôpital Edouard Herriot
    • Contact: Emmanuel POULET, Pr.; Phone Number: 04 72 11 00 09; Email: emmanuel.poulet@chu-lyon.fr
    • Sub-Investigator: Mohamed SAOUD, Pr.
  • Nantes, France, 44000
    • Not yet recruiting
    • CHU de Nantes
    • Contact: ANNE SAUVAGET, PHPD; Phone Number: 02 40 08 47 95; Email: Anne.sauvaget@chu-nantes.fr
    • Sub-Investigator: PHILIPPE DAMIER, PHPD
  • Toulouse, France, 31000
    • Not yet recruiting
    • Clinique St Exupery
    • Contact: CARLE-TOULEMONDE Guilhem; Phone Number: 05 32 18 32 39; Email: guilhemcarle@gmail.com
  • Gard
    • Nîmes, Gard, France, 30029
      • Recruiting
      • Centre Hospitalier Universitaire
      • Contact: Anissa MEGZARI; Phone Number: 04 66 68 30 52; Email: anissa.megzari@CHU-nimes.fr
      • Principal Investigator: Ismael CONEJERO, Dr
      • Sub-Investigator: Mocrane ABBAR, Dr
      • Sub-Investigator: Jorge LOPEZ CASTROMAN, Pr.
      • Sub-Investigator: Eric THOUVENOT, Pr.
      • Sub-Investigator: Fabricio PEREIRA, M.
  • Hérault
    • Montpellier, Hérault, France, 34090
      • Not yet recruiting
      • Hôpital La Colombière Service de Psychiatrie
      • Contact: Jérôme ATTAL, Dr.; Phone Number: 04 67 33 67 33; Email: j-attal@chu-montpellier.fr
    • Montpellier, Hérault, France, 34295
      • Not yet recruiting
      • CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie
      • Contact: Caroline ARQUIZAN, Dr; Phone Number: 04 67 33 74 13; Email: c-arquizan@chu-montpellier.fr
    • Montpellier, Hérault, France, 34295
      • Not yet recruiting
      • Hôpital Lapeyronie
      • Contact: Emilie OLIÉ, Dr; Phone Number: 04 67 33 85 81; Email: e-olie@chu-montpellier.fr
      • Sub-Investigator: Philippe COURTET
  • Île-de-France
    • Paris, Île-de-France, France, 75012
      • Not yet recruiting
      • Hôpital Saint-Antoine Service de Psychiatrie APHP
      • Contact: Stéphane MOUCHABAC, Dr.; Phone Number: 01 49 28 27 69; Email: stephane.mouchabac@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "active tDCS" group; 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.	Device: Neurostimulation with non-implanted electrodes; Neurostimulation with non-implanted electrodes
Sham Comparator: "sham tDCS" group; 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.	Device: Neurostimulation with non-implanted electrodes; Neurostimulation with non-implanted electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days after the intervention
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	1 month after the intervention
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	3 months after the intervention
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	6 months after the intervention
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).	7 days after the intervention
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).	1 month after the intervention
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).	6 month after the intervention
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	7 days after the intervention
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	1 month after the intervention
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	3 months after the intervention
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	3 months after the intervention
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)	7 days after the intervention
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)	3 months after the intervention
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)	6 months after the intervention
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.	7 days after the intervention
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.	1 month after the intervention
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.	3 months after the intervention
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.	6 months after the intervention
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)	7 days after the intervention
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)	1 month after the intervention
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)	3 months after the intervention
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)	6 months after the intervention
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.	7 days after the intervention
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.	1 month after the intervention
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.	3 months after the intervention
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.	6 months after the intervention
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.	7 days after the intervention
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.	1 month after the intervention
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.	3 months after the intervention
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.	6 months after the intervention
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).	From 2 days to 6 days after the intervention
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.	Day 0 and 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 at day 7	7 days after the intervention
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	1 month after the intervention
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	3 month after the intervention
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	6 month after the intervention
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	7 days after the intervention
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	1 month after the intervention
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	3 month after the intervention
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	6 month after the intervention
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.	Score at the CGI questionnaire	7 days after the intervention
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.	Score at the CGI questionnaire	1 month after the intervention
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.	Score at the CGI questionnaire	3 month after the intervention
Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.	Score at the CGI questionnaire	6 month after the intervention

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Ismael CONEJERO, Dr., CHU de Nîmes (Nîmes University Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Dissociative Disorders; Conversion Disorder; Hysteria
• Other Study ID Numbers: PHRC-N/2018/IC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No