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

Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-compulsive Disorders and Symptoms
• Intervention / Treatment: Other: bifocal stimulation with tDCS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Centre Hospitalier Henri Laborit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bifocal stimulation; Transcranial direct current Bifocal stimulation	Other: bifocal stimulation with tDCS; Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the persistence of therapeutic response at 45 days	Score improvement on the Y-BOCS after 45 days compared to the baseline	Day 45
Evaluate the persistence of therapeutic response at 105 days	Score improvement on the Y-BOCS after 105 days compared to the baseline	Day 105
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days	Score improvement of Hamilton and HDRS scales between the baseline and day 14	Day 14
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days	Score improvement of Hamilton and HDRS scales between the baseline and day 45	Day 45
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days	Score improvement of Hamilton and HDRS scales between the baseline and day 105	Day 105
Evaluate the effect of tDCS on the quality of life at day 14	Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14	Day 14
Evaluate the effect of tDCS on the quality of life at day 45	Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45	Day 45
Evaluate the effect of tDCS on global functioning at day 14	Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14	Day 14
Evaluate the effect of tDCS on global functioning at day 45	Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45	Day 45
Evaluate the effect of tDCS on social adjustment at day 14	Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14	Day 14
Evaluate the effect of tDCS on social adjustement at day 45	Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45	Day 45

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit
• Investigators: Study Director: Nematollah JAAFARI, Professor, Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2016
• Primary Completion (Actual): February 19, 2016
• Study Completion (Actual): May 12, 2017

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Supplementary motor area; Orbitofrontal cortex
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: tDCS-TOC pilote

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No