tDCS for Treatment Resistant Obsessive Compulsive Disorder

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

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-03

Study Completion Date

2022-02-24

Brief Summary

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It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active stimulation

10 sessions (1 per day during 2 week) of active tDCS stimulation

Group Type EXPERIMENTAL

Active stimulation

Intervention Type DEVICE

Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).

Sham Stimulation

10 sessions (1 per day during 2 week) of sham stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Patients will receive a Sham stimulation during 30 mn

Interventions

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Active stimulation

Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).

Intervention Type DEVICE

Sham stimulation

Patients will receive a Sham stimulation during 30 mn

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
* No current depressive and suicidal risks
* No epileptic pathology
* Age: Participants will be both males and females, 18-70 years of age included.
* Chronic Obsessive compulsive disorder ( Total Y-BOCS\>20 or Y-BOCS one subscale \> 15)
* Obsessive compulsive disorder resistant to pharmacology treatment :

1. at least 2 antidepressants (IRS type) (\> 12 weeks)
2. cognitive and comportment therapy since at least one year
* Treatment stability (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
* Patient hospitalized under duress
* Meets another diagnosis of axe 1 of DSM-IV
* Current depressive or suicidal risks
* 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