ClinicalTrials.gg
RecruitingNCT04097184CONVERSTIMUpdated Feb 13, 2025

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

An interventional study of Neurostimulation with non-implanted electrodes in Conversion Disorder, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 8 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Conversion Disorder

Browse trials for

03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's planned enrollment of 96 is above the median of 38 across 51 interventional studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 to MRI (for patients enrolled in Nîmes).
  • Acute eczema at the electrodes loci.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceNeurostimulation with non-implanted electrodes

    Neurostimulation with non-implanted electrodes

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months after the intervention

Secondary outcomes

  1. 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

    Time frame: 7 days after the intervention

  2. 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

    Time frame: 1 month after the intervention

  3. 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

    Time frame: 3 months after the intervention

  4. 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

    Time frame: 6 months after the intervention

  5. 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).

    Time frame: 7 days after the intervention

  6. 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).

    Time frame: 1 month after the intervention

  7. 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).

    Time frame: 6 month after the intervention

  8. 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 1. 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 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead

    Time frame: 7 days after the intervention

  9. 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 1. 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 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead

    Time frame: 1 month after the intervention

  10. 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 1. 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 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead

    Time frame: 3 months after the intervention

  11. 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 1. 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 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead

    Time frame: 3 months after the intervention

  12. 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)

    Time frame: 7 days after the intervention

  13. 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)

    Time frame: 3 months after the intervention

  14. 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)

    Time frame: 6 months after the intervention

  15. 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.

    Time frame: 7 days after the intervention

  16. 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.

    Time frame: 1 month after the intervention

  17. 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.

    Time frame: 3 months after the intervention

  18. 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.

    Time frame: 6 months after the intervention

  19. 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)

    Time frame: 7 days after the intervention

  20. 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)

    Time frame: 1 month after the intervention

  21. 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)

    Time frame: 3 months after the intervention

  22. 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)

    Time frame: 6 months after the intervention

  23. 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.

    Time frame: 7 days after the intervention

  24. 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.

    Time frame: 1 month after the intervention

  25. 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.

    Time frame: 3 months after the intervention

  26. 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.

    Time frame: 6 months after the intervention

  27. 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.

    Time frame: 7 days after the intervention

  28. 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.

    Time frame: 1 month after the intervention

  29. 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.

    Time frame: 3 months after the intervention

  30. 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.

    Time frame: 6 months after the intervention

  31. 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).

    Time frame: From 2 days to 6 days after the intervention

  32. 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.

    Time frame: Day 0 and Day 7

  33. 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

    Time frame: 7 days after the intervention

  34. 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

    Time frame: 1 month after the intervention

  35. 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

    Time frame: 3 month after the intervention

  36. 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

    Time frame: 6 month after the intervention

  37. 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

    Time frame: 7 days after the intervention

  38. 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

    Time frame: 1 month after the intervention

  39. 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

    Time frame: 3 month after the intervention

  40. 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

    Time frame: 6 month after the intervention

  41. Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.

    Score at the CGI questionnaire

    Time frame: 7 days after the intervention

  42. Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.

    Score at the CGI questionnaire

    Time frame: 1 month after the intervention

  43. Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.

    Score at the CGI questionnaire

    Time frame: 3 month after the intervention

  44. Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.

    Score at the CGI questionnaire

    Time frame: 6 month after the intervention

07

Study locations

1 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04097184
Responsible party
Sponsor
First posted
Sep 20, 2019
Start date
Mar 5, 2021
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Feb 13, 2025

Study contacts

Ismael CONEJERO, Dr.
Contact
ismael.conejero@gmail.com
07 70 21 62 38
Ismael CONEJERO, Dr.
principal investigator · CHU de Nîmes (Nîmes University Hospital)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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