Clinical trial NCT03284671: tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study
Official title: Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorders and Symptoms
Keywords: Transcranial Direct Current Stimulation
Supplementary motor area
Orbitofrontal cortex
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Patients must present all of the following criteria in order to be eligible:

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.

Primary outcomes:
measure: The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
timeFrame: Day 14
Secondary outcomes:
measure: Evaluate the persistence of therapeutic response at 45 days
timeFrame: Day 45
measure: Evaluate the persistence of therapeutic response at 105 days
timeFrame: Day 105
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
timeFrame: Day 14
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
timeFrame: Day 45
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
timeFrame: Day 105
measure: Evaluate the effect of tDCS on the quality of life at day 14
timeFrame: Day 14
measure: Evaluate the effect of tDCS on the quality of life at day 45
timeFrame: Day 45
measure: Evaluate the effect of tDCS on global functioning at day 14
timeFrame: Day 14
measure: Evaluate the effect of tDCS on global functioning at day 45
timeFrame: Day 45
measure: Evaluate the effect of tDCS on social adjustment at day 14
timeFrame: Day 14
measure: Evaluate the effect of tDCS on social adjustement at day 45
timeFrame: Day 45
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Nematollah JAAFARI, Professor
role: STUDY_DIRECTOR
References: