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tDCS for Treatment Resistant Obsessive Compulsive Disorder (tDCS-TOC)

C

Centre Hospitalier Henri Laborit

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Device: Sham stimulation
Device: Active stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03304600
2016-A01983-48

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

83 participants in 2 patient groups

Active stimulation
Experimental group
Description:
10 sessions (1 per day during 2 week) of active tDCS stimulation
Treatment:
Device: Active stimulation
Sham Stimulation
Sham Comparator group
Description:
10 sessions (1 per day during 2 week) of sham stimulation
Treatment:
Device: Sham stimulation

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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