Conversion DisorderCONVERSTIMNCT04097184
Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients
A study testing Neurostimulation with non-implanted electrodes in people with Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Conversion Disorder
- What is being tested?
- Neurostimulation with non-implanted electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 8 sitesFrance
- Study dates
- 5 Mar 2021to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Hospices Civils de Lyon Hôpital Edouard Herriot
Lyon, 69003
Emmanuel POULET, Pr., 04 72 11 00 09, emmanuel.poulet@chu-lyon.fr
Mohamed SAOUD, Pr.
- Not yet recruiting
Hôpital La Colombière Service de Psychiatrie
Montpellier, Hérault, 34090
Jérôme ATTAL, Dr., 04 67 33 67 33, j-attal@chu-montpellier.fr
- Not yet recruiting
CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie
Montpellier, Hérault, 34295
Caroline ARQUIZAN, Dr, 04 67 33 74 13, c-arquizan@chu-montpellier.fr
- Not yet recruiting
Hôpital Lapeyronie
Montpellier, Hérault, 34295
Emilie OLIÉ, Dr, 04 67 33 85 81, e-olie@chu-montpellier.fr
Philippe COURTET
- Not yet recruiting
CHU de Nantes
Nantes, 44000
ANNE SAUVAGET, PHPD, 02 40 08 47 95, Anne.sauvaget@chu-nantes.fr
PHILIPPE DAMIER, PHPD
- Recruiting
Centre Hospitalier Universitaire
Nîmes, Gard, 30029
Anissa MEGZARI, 04 66 68 30 52, anissa.megzari@CHU-nimes.fr
Ismael CONEJERO, Dr
- Not yet recruiting
Hôpital Saint-Antoine Service de Psychiatrie APHP
Paris, Île-de-France Region, 75012
Stéphane MOUCHABAC, Dr., 01 49 28 27 69, stephane.mouchabac@aphp.fr
- Not yet recruiting
Clinique St Exupery
Toulouse, 31000
CARLE-TOULEMONDE Guilhem, 05 32 18 32 39, guilhemcarle@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Conversion Disorder
- Being tested
- Neurostimulation with non-implanted electrodes
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation with non-implanted electrodesDevice
Neurostimulation with non-implanted electrodes
| Study group | Role | What they receive |
|---|---|---|
| "active tDCS" group | Active comparator | 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. Receives: Device: Neurostimulation with non-implanted electrodes |
| "sham tDCS" group | Sham comparator | 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. Receives: Device: Neurostimulation with non-implanted electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after the intervention
Secondary outcomes (44)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start5 Mar 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conversion DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicentre controlled randomized, double-blind, two-arm study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismael CONEJERO, Dr., Principal investigator, CHU de Nîmes (Nîmes University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097184
- Sponsor's protocol ID
- PHRC-N/2018/IC-01
- Acronym
- CONVERSTIM
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay
- ClinicalTrials.gov ID
- NCT04097184
- Acronym / sponsor ID
- CONVERSTIM / PHRC-N/2018/IC-01
- Conditions
- Conversion Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective multicentre controlled randomized, double-blind, two-arm study
| Arm | Type | Receives |
|---|---|---|
| "active tDCS" group | Active comparator | Device: Neurostimulation with non-implanted electrodesPatients 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. |
| "sham tDCS" group | Sham comparator | Device: Neurostimulation with non-implanted electrodesPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostimulation with non-implanted electrodesNeurostimulation with non-implanted electrodes | Device | "active tDCS" group, "sham tDCS" group |
Primary outcome
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).
44 secondary outcomes
Evaluation of the efficacy on motor symptoms at D7 with NIHSS
Time frame: 7 days after the intervention
Evaluation of the persistence of efficacy on motor symptoms at 1 month
Time frame: 1 month after the intervention
Evaluation of the persistence of efficacy on motor symptoms at 3 months
Time frame: 3 months after the intervention
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 disability with EDSS score at D7.
Time frame: 7 days after the intervention
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 on motor disability with EDSS at 6 months.
Time frame: 6 month after the intervention
WHO score at D7
Time frame: 7 days after the intervention
WHO score at 1 month
Time frame: 1 month after the intervention
WHO score at 3 months
Time frame: 3 months after the intervention
WHO score at 6 months
Time frame: 3 months after the intervention
CGI (Clinical Global Impression) scores at Day 7
Time frame: 7 days after the intervention
CGI (Clinical Global Impression) score at 3 months
Time frame: 3 months after the intervention
CGI (Clinical Global Impression) score at 6 months
Time frame: 6 months after the intervention
Modified Rankin (mRS) score at D7
Time frame: 7 days after the intervention
Modified Rankin (mRS) score at 1 month
Time frame: 1 month after the intervention
Modified Rankin (mRS) score at 3 months
Time frame: 3 months after the intervention
Modified Rankin (mRS) score at 6 months
Time frame: 6 months after the intervention
Evaluation of disability related to abnormal movements - CGI at D7.
Time frame: 7 days after the intervention
Evaluation of disability related to abnormal movements - CGI at 1 month.
Time frame: 1 month after the intervention
Evaluation of disability related to abnormal movements - CGI at 3 months.
Time frame: 3 months after the intervention
Evaluation of disability related to abnormal movements - CGI at 6 months.
Time frame: 6 months after the intervention
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at D7
Time frame: 7 days after the intervention
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 1 month
Time frame: 1 month after the intervention
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 3 months .
Time frame: 3 months after the intervention
Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months after the intervention
Tolerance to tDCS stimulation D2 - D6 Brunoni
Time frame: 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.
Time frame: Day 0 and Day 7
Evaluation of Dissociative Experiences Scale
Time frame: 7 days after the intervention
Evaluation of Dissociative Experiences Scale
Time frame: 1 month after the intervention
Evaluation of Dissociative Experiences Scale
Time frame: 3 month after the intervention
Evaluation of Dissociative Experiences Scale
Time frame: 6 month after the intervention
Evaluate the evolution of dissociation Experiences Scale
Time frame: 7 days after the intervention
Evaluate the evolution of dissociation Experiences Scale
Time frame: 1 month after the intervention
Evaluate the evolution of dissociation Experiences Scale
Time frame: 3 month after the intervention
Evaluate the evolution of dissociation Experiences Scale
Time frame: 6 month after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ismael CONEJERO, Dr. principal investigator
CHU de Nîmes (Nîmes University Hospital)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation with non-implanted electrodes in people with Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismael CONEJERO, Dr. (07 70 21 62 38, ismael.conejero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.