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tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study

NCT ID: NCT03284671

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-19

Study Completion Date

2017-05-12

Brief Summary

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The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.

Detailed Description

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Conditions

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Obsessive-compulsive Disorders and Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bifocal stimulation

Transcranial direct current Bifocal stimulation

Group Type EXPERIMENTAL

bifocal stimulation with tDCS

Intervention Type OTHER

Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

Interventions

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bifocal stimulation with tDCS

Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS),
* Age: Participants will be both males and females, 18-70 years of age included.
* No current depressive and suicidal risks,
* No epileptic pathology,
* Chronic evolution ( Total Y-BOCS\>20 ),
* Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year,
* Stability treatment (antidepressants) for more than 12 weeks without significant improvement,
* Affiliation to a social security system (recipient or assignee),
* Signed written inform consent form.

Exclusion Criteria

* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
* Patient under curators
* Meets another diagnosis of axe 1 of DSM-IV,
* Current depressive or suicidal risks,
* Patient with a benzodiazepine treatment,
* Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) ,
* Epileptic patient,
* Patient with a medical history of cranial trauma,
* Patient unable to give his or hers informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Henri Laborit

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nematollah JAAFARI, Professor

Role: STUDY_DIRECTOR

Centre Hospitalier Henri Laborit

Locations

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Centre Hospitalier Henri Laborit

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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tDCS-TOC pilote

Identifier Type: -

Identifier Source: org_study_id