Informations générales (source: ClinicalTrials.gov)

NCT04097184 En recrutement
Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay (CONVERSTIM)
Interventional
  • Trouble de conversion
  • Troubles dissociatifs
  • Hystérie
N/A
Centre Hospitalier Universitaire de Nīmes (Voir sur ClinicalTrials)
mars 2021
septembre 2025
24 mai 2025
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Saint Antoine Stéphane MOUCHABAC, Dr. Recrutement non commencé Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie - 34295 - Montpellier - Hérault - France Caroline ARQUIZAN, Dr Recrutement non commencé Contact (sur clinicalTrials)
Hôpital La Colombière Service de Psychiatrie - 34090 - Montpellier - Hérault - France Jérôme ATTAL, Dr. Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Lapeyronie - 34295 - Montpellier - Hérault - France Emilie OLIÉ, Dr Recrutement non commencé Contact (sur clinicalTrials)
Hospices Civils de Lyon Hôpital Edouard Herriot - 69003 - Lyon - France Emmanuel POULET, Pr. Recrutement non commencé Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Universitaire - 30029 - Nîmes - Gard - France Anissa MEGZARI En recrutement Contact (sur clinicalTrials)
CHU de Nantes - 44000 - Nantes - France ANNE SAUVAGET, PHPD Recrutement non commencé Contact (sur clinicalTrials)
Clinique St Exupery - 31000 - Toulouse - France CARLE-TOULEMONDE Guilhem Recrutement non commencé Contact (sur clinicalTrials)

Critères

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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



- 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.