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

Not Applicable

Completed

• Conditions: Obsessive-compulsive Disorders and Symptoms

• Registration Number: NCT03284671
• Lead Sponsor: Centre Hospitalier Henri Laborit

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-19
• Primary Completion: 2016-02-19
• Study Completion: 2017-05-12
• Status Verified: 2017-09
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Day 14	Score improvement on the Y-BOCS after 14 days compared to the baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France