Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hospices Civils de Lyon Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie
NOT_YET_RECRUITING
Montpellier
Hôpital La Colombière Service de Psychiatrie
NOT_YET_RECRUITING
Montpellier
Hôpital Lapeyronie
NOT_YET_RECRUITING
Montpellier
CHU de Nantes
NOT_YET_RECRUITING
Nantes
Centre Hospitalier Universitaire
RECRUITING
Nîmes
Hôpital Saint-Antoine Service de Psychiatrie APHP
NOT_YET_RECRUITING
Paris
Clinique St Exupery
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Ismael CONEJERO, Dr.
ismael.conejero@gmail.com
07 70 21 62 38
Time Frame
Start Date: 2021-03-05
Estimated Completion Date: 2025-09
Participants
Target number of participants: 96
Treatments
Active_comparator: active tDCS group
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.
Sham_comparator: sham tDCS group
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.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov