NCT04097184 Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients
| NCT ID | NCT04097184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Conversion Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2021-03-05 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2021-03-05 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Ismael CONEJERO, Dr.
PRINCIPAL INVESTIGATOR
CHU de Nîmes (Nîmes University Hospital)
Frequently Asked Questions
Who can join the NCT04097184 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Conversion Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04097184 currently recruiting?
Yes, NCT04097184 is actively recruiting participants. Contact the research team at ismael.conejero@gmail.com for enrollment information.
Where is the NCT04097184 trial being conducted?
This trial is being conducted at Nîmes, France, Montpellier, France, Montpellier, France, Montpellier, France and 4 additional locations.
Who is sponsoring the NCT04097184 clinical trial?
NCT04097184 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Ismael CONEJERO, Dr. at CHU de Nîmes (Nîmes University Hospital). The trial plans to enroll 96 participants.