tDCS for Treatment Resistant Obsessive Compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Active stimulation; Device: Sham stimulation

• Registration Number: NCT03304600
• Lead Sponsor: Centre Hospitalier Henri Laborit

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Study Start: 2017-11-03
• Primary Completion: 2022-02-24
• Study Completion: 2022-02-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active stimulation	Active stimulation	10 sessions (1 per day during 2 week) of active tDCS stimulation
Sham Stimulation	Sham stimulation	10 sessions (1 per day during 2 week) of sham stimulation

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale (YBOCS) score	2 weeks	The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups

Secondary Outcome Measures

Name	Time	Method
Brown Assessment of Beliefs Scale (BABS)	Month 3	Change from baseline to month 3 in above scales between treatment groups;
Yale Brown Obsessive Compulsive Scale (YBOCS),	Month 3	ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.
Hospital Anxiety and Depression scale (HAD)	Month 3	Change from baseline to month 3 in above scales between treatment groups;
Yale Brown Obsessive Compulsive Scale (YBOCS)	Month 1	i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.
Brief Anxiety Scale (BAS)	Month 3	Change from baseline to month 3 in above scales between treatment groups;
Montgomery and Asberg Depression Rating Scale (MADRS)	Month 3	Change from baseline to month 3 in above scales between treatment groups;
Sheehan Disability Scale, (SDS)	Month 3	Change from baseline to month 3 in above scales between treatment groups;
Clinical Global Impression (CGI)	Month 3	Change from baseline to month 3 in above scales between treatment groups;

Trial Locations

Locations (4)

CHU de Nantes; 🇫🇷 Nantes, France

C.H. Guillaume Regnier; 🇫🇷 Rennes, France

Hospices Civils De Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France