Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04097184

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-02-13

96

Participants Needed

8

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has given informed and signed consent
  • Patient is aged 18 to 65 years
  • Patient is hospitalized or followed in consultation
  • Patient is available for 6 months of follow-up
  • Patient meets current DSM-5 criteria for motor conversion disorder lasting more than 10 days, with initial EDSS score ≥ 3 or initial WHO score ≥ 2
Not Eligible

You will not qualify if you...

  • Patient is participating in another interventional trial
  • Patient refuses to sign consent
  • Patient cannot be properly informed
  • Patient is pregnant or breastfeeding
  • Neurological exam and brain/spinal MRI show organic neurological disease
  • Current episode of mania, hypomania, substance abuse (excluding smoking), schizophrenia, or severe neurological disease (epilepsy, stroke, brain tumor)
  • Patient has contraindication to MRI (for patients enrolled in N�eemes)
  • Acute eczema at electrode sites

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Centre Hospitalier Universitaire

Nîmes, Gard, France, 30029

Actively Recruiting

2

Hôpital La Colombière Service de Psychiatrie

Montpellier, Hérault, France, 34090

Not Yet Recruiting

3

CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie

Montpellier, Hérault, France, 34295

Not Yet Recruiting

4

Hôpital Lapeyronie

Montpellier, Hérault, France, 34295

Not Yet Recruiting

5

Hospices Civils de Lyon Hôpital Edouard Herriot

Lyon, France, 69003

Not Yet Recruiting

6

CHU de Nantes

Nantes, France, 44000

Not Yet Recruiting

7

Clinique St Exupery

Toulouse, France, 31000

Not Yet Recruiting

8

Hôpital Saint-Antoine Service de Psychiatrie APHP

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

Not Yet Recruiting

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Research Team

I

Ismael CONEJERO, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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