tDCS for Treatment Resistant Obsessive Compulsive Disorder (tDCS-TOC)

Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Active stimulation; Device: Sham stimulation

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hospices civils de Lyon
  • Nantes, France, 44093
    • CHU de Nantes
  • Poitiers, France, 86021
    • Centre Hospitalier Henri Laborit
  • Rennes, France, 35703
    • C.H. Guillaume Regnier

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active stimulation; 10 sessions (1 per day during 2 week) of active tDCS stimulation	Device: Active stimulation; Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
SHAM_COMPARATOR: Sham Stimulation; 10 sessions (1 per day during 2 week) of sham stimulation	Device: Sham stimulation; Patients will receive a Sham stimulation during 30 mn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Brown Obsessive Compulsive Scale (YBOCS) score	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	2 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Safety of the tDCS treatment : assessed by physical examination during each tDCS session; any other adverse events (AEs)	3 Month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit
• Collaborators: Ministry of Health, France
• Investigators: Study Director: Damien HEIT, MD, Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2017
• Primary Completion (ACTUAL): February 24, 2022
• Study Completion (ACTUAL): February 24, 2022

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (ACTUAL): October 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: OCD; tDCS
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2016-A01983-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No