tDCS for Treatment Resistant Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

— tDCS-TOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304600
• Other study ID #: 2016-A01983-48
• Status: Completed
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Henri Laborit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Active stimulation
Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
• Sham stimulation
Patients will receive a Sham stimulation during 30 mn

Locations

Country	Name	City	State
France	Hospices Civils De Lyon	Lyon
France	CHU de Nantes	Nantes
France	Centre Hospitalier Henri Laborit	Poitiers
France	C.H. Guillaume Regnier	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events	Safety of the tDCS treatment : assessed by physical examination during each tDCS session; any other adverse events (AEs)	3 Month
Primary	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	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
Secondary	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
Secondary	Clinical Global Impression (CGI)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Clinical Global Impression (CGI)	Change from baseline to month 3 in above scales between treatment groups;	Month 3
Secondary	Brown Assessment of Beliefs Scale (BABS)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Brown Assessment of Beliefs Scale (BABS)	Change from baseline to month 3 in above scales between treatment groups;	Month 3
Secondary	Brief Anxiety Scale (BAS)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Brief Anxiety Scale (BAS)	Change from baseline to month 3 in above scales between treatment groups;	Month 3
Secondary	Montgomery and Asberg Depression Rating Scale (MADRS)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Montgomery and Asberg Depression Rating Scale (MADRS)	Change from baseline to month 3 in above scales between treatment groups;	Month 3
Secondary	Hospital Anxiety and Depression scale (HAD)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Hospital Anxiety and Depression scale (HAD)	Change from baseline to month 3 in above scales between treatment groups;	Month 3
Secondary	Sheehan Disability Scale, (SDS)	Change from baseline to month 1 in above scales between treatment groups;	Month 1
Secondary	Sheehan Disability Scale, (SDS)	Change from baseline to month 3 in above scales between treatment groups;	Month 3