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

NCT04097184 | Recruiting

• 1 other identifier: PHRC-N/2018/IC-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 8

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.

Conditions

Conversion Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months after the intervention

Secondary Outcomes (44)

• Evaluation of the efficacy on motor symptoms at D7 with NIHSS

  7 days after the intervention

• Evaluation of the persistence of efficacy on motor symptoms at 1 month

  1 month after the intervention

• Evaluation of the persistence of efficacy on motor symptoms at 3 months

  3 months after the intervention

• Evaluation of the persistence of efficacy on motor symptoms at 6 months

  6 months after the intervention

• Evaluation of the efficacy on motor disability with EDSS score at D7.

  7 days after the intervention

Study Arms (2)

"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.

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.

Device: Neurostimulation with non-implanted electrodes

Interventions

Neurostimulation with non-implanted electrodes DEVICE

Neurostimulation with non-implanted electrodes

"active tDCS" group; "sham tDCS" group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (8)

Centre Hospitalier Universitaire

Nîmes, Gard, 30029, France

RECRUITING

Hôpital La Colombière Service de Psychiatrie

Montpellier, Hérault, 34090, France

NOT YET RECRUITING

CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie

Montpellier, Hérault, 34295, France

NOT YET RECRUITING

Hôpital Lapeyronie

Montpellier, Hérault, 34295, France

NOT YET RECRUITING

Hospices Civils de Lyon Hôpital Edouard Herriot

Lyon, 69003, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

Clinique St Exupery

Toulouse, 31000, France

NOT YET RECRUITING

Hôpital Saint-Antoine Service de Psychiatrie APHP

Paris, Île-de-France Region, 75012, France

NOT YET RECRUITING

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Ismael CONEJERO, Dr.

  CHU de Nîmes (Nîmes University Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismael CONEJERO, Dr.

CONTACT

07 70 21 62 38; ismael.conejero@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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").
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicentre controlled randomized, double-blind, two-arm study

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: March 5, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)