NCT03284671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

September 7, 2017

Last Update Submit

September 12, 2017

Conditions

Obsessive-compulsive Disorders and Symptoms

Keywords

Transcranial Direct Current StimulationSupplementary motor areaOrbitofrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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

    Score improvement on the Y-BOCS after 14 days compared to the baseline

    Day 14

Secondary Outcomes (11)

  • Evaluate the persistence of therapeutic response at 45 days

    Day 45

  • Evaluate the persistence of therapeutic response at 105 days

    Day 105

  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days

    Day 14

  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days

    Day 45

  • Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days

    Day 105

  • +6 more secondary outcomes

Study Arms (1)

bifocal stimulation

EXPERIMENTAL

Transcranial direct current Bifocal stimulation

Other: bifocal stimulation with tDCS

Interventions

bifocal stimulation with tDCSOTHER

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

bifocal stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Nematollah JAAFARI, Professor

    Centre Hospitalier Henri Laborit

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 15, 2017

Study Start

February 19, 2016

Primary Completion

February 19, 2016

Study Completion

May 12, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)