Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097184
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date September 20, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
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. [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Evaluation of the efficacy on motor symptoms at D7 with NIHSS [ Time Frame: 7 days after the intervention ]
    Evaluation of the efficacy on motor symptoms at Day 7 with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
  • Evaluation of the persistence of efficacy on motor symptoms at 1 month [ Time Frame: 1 month after the intervention ]
    Evaluation of the efficacy on motor symptoms at 1 month with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
  • Evaluation of the persistence of efficacy on motor symptoms at 3 months [ Time Frame: 3 months after the intervention ]
    Evaluation of the efficacy on motor symptoms at 3 months with the National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
  • Evaluation of the persistence of efficacy on motor symptoms at 6 months [ Time Frame: 6 months after the intervention ]
    Evaluation of the efficacy on motor symptoms at 6 months with National Institute of Health Stroke Score (NIHSS). The National Institute of Health Stroke Score includes the following domains : level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke). Duration = 10 minutes
  • Evaluation of the efficacy on motor disability with EDSS score at D7. [ Time Frame: 7 days after the intervention ]
    Evaluation of the efficacy of the intervention on motor symptoms at D7 using the Expanded Disability Status Scale (EDSS). The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
  • Evaluation of the persistence of efficacy on motor disability with EDSS at 1 month [ Time Frame: 1 month after the intervention ]
    Evaluation of the persistence of efficacy of the intervention using the Expanded Disability Status Scale (EDSS) at 1 month. The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
  • Evaluation of the persistence of efficacy on motor disability with EDSS at 6 months. [ Time Frame: 6 month after the intervention ]
    Evaluation of the persistence of efficacy of the intervention on motor disability using the Expanded Disability Status Scale (EDSS) at 6 months.The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale was developed by John F. Kurtzke and an EDSS calculator is available on line. The EDSS is based on a neurological examination by a clinician, however a number of versions have been developed to enable patient self-administration.The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral,other. The scale ranges from 0.0 (normal neurological examination) to 10.0 (death due to multiple sclerosis).
  • WHO score at D7 [ Time Frame: 7 days after the intervention ]
    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
  • WHO score at 1 month [ Time Frame: 1 month after the intervention ]
    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
  • WHO score at 3 months [ Time Frame: 3 months after the intervention ]
    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
  • WHO score at 6 months [ Time Frame: 3 months after the intervention ]
    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
  • CGI (Clinical Global Impression) scores at Day 7 [ Time Frame: 7 days after the intervention ]
    Evaluation of the efficacy on motor disability with Clinical Global Impression score at Day 7. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • CGI (Clinical Global Impression) score at 3 months [ Time Frame: 3 months after the intervention ]
    Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • CGI (Clinical Global Impression) score at 6 months [ Time Frame: 6 months after the intervention ]
    Evaluation of the persistence of efficacy of the intervention on motor disability with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • Modified Rankin (mRS) score at D7 [ Time Frame: 7 days after the intervention ]
    Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at D7 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
  • Modified Rankin (mRS) score at 1 month [ Time Frame: 1 month after the intervention ]
    Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
  • Modified Rankin (mRS) score at 3 months [ Time Frame: 3 months after the intervention ]
    Evaluation of the efficacy on motor disability with modified Rankin (mRS) scores at 1 month.The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
  • Modified Rankin (mRS) score at 6 months [ Time Frame: 6 months after the intervention ]
    Evaluation of the efficacy on motor disability with modified Rankin (mRS) score at 6 months. The Modified Rankin (mRS) score is a scale ranging from 0 - 6 with 0 being no symptoms at all. 3 = moderate disability despite symptoms but able to walk without asistance and 6 = dead.
  • Evaluation of disability related to abnormal movements - CGI at D7. [ Time Frame: 7 days after the intervention ]
    Evaluate the efficacy on disability related to abnormal movements with Clinical Global Impression scores at Day 7.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • Evaluation of disability related to abnormal movements - CGI at 1 month. [ Time Frame: 1 month after the intervention ]
    Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 1 month.The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • Evaluation of disability related to abnormal movements - CGI at 3 months. [ Time Frame: 3 months after the intervention ]
    Evaluate the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 3 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • Evaluation of disability related to abnormal movements - CGI at 6 months. [ Time Frame: 6 months after the intervention ]
    Evaluation of the persistence of efficacy on disability related to abnormal movements with Clinical Global Impression scores at 6 months. The CGI is a set of two scales with points ranging from 1 -7. The first set describes the Severity of Illness ( 1 = no illness or symptoms of disorder for the past 7 days and 7 = among the most drastically ill patients) The second set describes the Global Improvement (1 = very much improved, 7 = very much worse)
  • Efficacy on depression and anxiety level assessed with the HAD score (HADS) at D7 [ Time Frame: 7 days after the intervention ]
    Evaluation of the efficacy of the intervention on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at D7. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows:
    • 0-7: normal
    • 8-10: average
    • 11-14: moderate
    • 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
  • Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 1 month [ Time Frame: 1 month after the intervention ]
    Evaluation of the persistence of efficacy on depression and anxiety level with the Hospital Anxiety and Depression Scale (HADS) at 1 month. The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows:
    • 0-7: normal
    • 8-10: average
    • 11-14: moderate
    • 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
  • Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 3 months . [ Time Frame: 3 months after the intervention ]
    Evaluation of the persistence of efficacy on depression and anxiety level assessed with the Hospital Anxiety and Depression Scale (HADS) at D7 and persistence at 3 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows:
    • 0-7: normal
    • 8-10: average
    • 11-14: moderate
    • 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
  • Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months. [ Time Frame: 6 months after the intervention ]
    Evaluation of the persistence of efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.The Hospital Anxiety and Depression Scale (HADS) questionnaire (Zigmond and Snaith 1983) validated in French (Lépine et al., 1985) is commonly used in screening for anxio-depressive disorders in studies; it is The HADS questionnaire consists of 14 questions (7 questions about anxiety and 7 questions about depression). Each question is an MCQ with four possible answers. The final score gives a ranking of anxiety and depressive symptoms as follows:
    • 0-7: normal
    • 8-10: average
    • 11-14: moderate
    • 15 to 21: severe This scale is used in this study to characterize the state of anxiety of the population and therefore for descriptive purposes.
  • Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at D7 [ Time Frame: 7 days after the intervention ]
    Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at D7.
  • Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 1 month [ Time Frame: 1 month after the intervention ]
    Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 1 month.
  • Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 3 months [ Time Frame: 3 months after the intervention ]
    Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 3 months.
  • Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 6 months [ Time Frame: 6 months after the intervention ]
    Evaluation of the interaction between time from symptom onset to inclusion in the study, the initial severity of abnormal movements and the efficacy of motor symptom treatment measured with EDSS at 6 months.
  • Tolerance to tDCS stimulation D2 - D6 Brunoni [ Time Frame: From 2 days to 6 days after the intervention ]
    Evaluate the tolerance to tDCS stimulation sessions from D2 to D6 with Brunoni's questionnaire.To monitor and evaluate the potential adverse effects of tDCS in patients receiving this treatment, Brunoni et al. (2011) proposed a structured questionnaire. The patient answers questions regarding symptoms or side-effects on different parts of the body and their severity ranges from 1 - 4 (1 = absent, 2 = mild, 3 = moderate, 4 = severe). The probability of these symptoms or side-effects being related to the tDCS stimulation treatment is also noted from 1 - 5 ( 1 = none, 2 = remote, 3 = possible, 4 = probable, 5 = definite).
  • Correlation between putative modification of motor symptoms and changes in activity (rest / motor imagery task) of the PFDLC monitored by brain fMRI at Day 0 and Day 7. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients
Official Title  ICMJE Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay
Brief Summary

Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date.

The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.

However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced.

Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

Detailed Description

Conversion disorder, also called "functional neurological disorder" (DSM-5), refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments (Carson et al. 2000) and the symptoms persist in 35% of patients after 12 years of evolution (Stone et al. 2003). Despite a poor prognosis, no treatments have been validated to date.

The development of non-invasive brain stimulation techniques has allowed the creation of focused treatments on dysfunctional brain regions associated with motor conversion disorder. A hypoactivation of prefrontal dorso-lateral cortex (PFDLC) underlies the course of functional motor symptoms (Spence et al. 2000); (Voon et al.2011); (Conejero et al. 2017). Results of the HYCORE study that the investigators conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.

However, in the majority of repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted (Pollak et al. 2014) and the clinical improvement was related to self-suggestion induced by the motor response produced.

Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective multicentre controlled randomized, double-blind, two-arm study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Patients will then be randomized and assigned to one of the 2 groups: the first group will receive a series of 10 effective stimulation sessions (experimental group "active tDCS") and the second group will receive a series of 10 placebo stimulation sessions (control group "sham tDCS").
Primary Purpose: Treatment
Condition  ICMJE Conversion Disorder
Intervention  ICMJE Device: Neurostimulation with non-implanted electrodes
Neurostimulation with non-implanted electrodes
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Device: Neurostimulation with non-implanted electrodes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • The patient is participating in another interventional trial.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient.
  • The patient is pregnant or breastfeeding.
  • Specialized neurological clinical examination and the performing of brain and medullary MRI reveal an organic neurological involvement.
  • Current episode of mania, hypomania, diagnosis of substance abuse/dependence (excluding smoking), diagnosis of schizophrenia over lifetime, severe neurological pathology (epilepsy, stroke, brain tumor).
  • Patient with a contraindication to MRI (for patients enrolled in Nîmes).
  • Acute eczema at the electrodes loci.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ismael CONEJERO, Dr. 07 70 21 62 38 ismael.conejero@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097184
Other Study ID Numbers  ICMJE PHRC-N/2018/IC-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ismael CONEJERO, Dr. CHU de Nîmes (Nîmes University Hospital)
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP