Dorso-lateral Prefrontal Cortex Stimulation for Motor Conversion Disorder
Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay
NA · Centre Hospitalier Universitaire de Nīmes · NCT04097184
This study is testing if a new type of brain stimulation can help people with motor conversion disorder improve their movement and regain control over their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Locations | 8 sites (Nîmes, Gard and 7 other locations) |
| Trial ID | NCT04097184 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of non-invasive brain stimulation targeting the dorso-lateral prefrontal cortex in patients with motor conversion disorder. The study aims to activate this brain region to restore executive control and improve motor symptoms, which are often debilitating and resistant to traditional treatments. Patients will undergo neurostimulation with non-implanted electrodes and will be followed for six months to assess outcomes. The trial is based on previous findings linking hypoactivation of the prefrontal cortex to persistent motor disability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with motor conversion disorder lasting more than 10 days.
Not a fit: Patients with organic neurological involvement or those currently participating in another interventional trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from motor conversion disorder.
How similar studies have performed: Previous studies have shown promising results with non-invasive brain stimulation techniques, suggesting potential efficacy in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must have given his/her informed and signed consent. * The patient is at least (≥) 18 years old and 65 years old at the most (≤). The risk of an increased frequency of somatic comorbidity, drug co-prescription, and cognitive impairment prompts us to limit recruitment to age 65 in this study. * The patient is hospitalized or followed in consultation. * Patient is available for a follow-up of 6 months. * With current DSM-5 criteria for conversion disorder during more than 10 days, motor type (i.e. with paralysis or motor weakness) and initial EDSS score ≥ 3 or initial WHO Score is ≥ 2 Exclusion Criteria: * The patient is participating in another interventional trial. * The patient refuses to sign the consent. * It is impossible to correctly inform the patient. * The patient is pregnant or breastfeeding. * Specialized neurological clinical examination and the performing of brain and medullary MRI reveal an organic neurological involvement. * Current episode of mania, hypomania, diagnosis of substance abuse/dependence (excluding smoking), diagnosis of schizophrenia over lifetime, severe neurological pathology (epilepsy, stroke, brain tumor). * Patient with a contraindication to MRI (for patients enrolled in Nîmes). * Acute eczema at the electrodes loci.
Where this trial is running
Nîmes, Gard and 7 other locations
- Centre Hospitalier Universitaire — Nîmes, Gard, France (RECRUITING)
- Hôpital La Colombière Service de Psychiatrie — Montpellier, Hérault, France (NOT_YET_RECRUITING)
- CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie — Montpellier, Hérault, France (NOT_YET_RECRUITING)
- Hôpital Lapeyronie — Montpellier, Hérault, France (NOT_YET_RECRUITING)
- Hospices Civils de Lyon Hôpital Edouard Herriot — Lyon, France (NOT_YET_RECRUITING)
- CHU de Nantes — Nantes, France (NOT_YET_RECRUITING)
- Clinique St Exupery — Toulouse, France (NOT_YET_RECRUITING)
- Hôpital Saint-Antoine Service de Psychiatrie APHP — Paris, Île-de-France Region, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Ismael CONEJERO, Dr. — CHU de Nîmes (Nîmes University Hospital)
- Study coordinator: Ismael CONEJERO, Dr.
- Email: ismael.conejero@gmail.com
- Phone: 07 70 21 62 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Conversion Disorder