tDCS as an add-on Treatment in SSRI-resistant OCD (TDCSTOC)

Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial

The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Study Overview

• Status: Unknown
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Sham tDCS; Device: transcranial dirrect current stimulation

Detailed Description

Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)

Statistical analysis to address the primary and secondary objectives:

Chi squared test will be applied for quantitative data.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Centre Hospitalier le Vinatier
    • Contact: remy bation, MD; Phone Number: 33437915565; Email: remy.bation@chu-lyon.fr

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:

• patients diagnosed with OCD according to DSM V criteria
• YBOCS score of 16 and above, stable (<20% of variation) during at least one month.
• have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
• age between 18 and 70
• voluntary and competent to consent

Exclusion Criteria:

• Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual)
• schizophrenia and other psychotic disorder
• drugs or alcohol abuse
• acutely suicidal
• significant head injury, or of any neurosurgical procedure with implanted material
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active tDCS; patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline	Device: transcranial dirrect current stimulation; The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline; Other Names: tdcs
Placebo Comparator: SHAM tDCS; The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.	Device: Sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month	% of improvement compare to baseline	1 month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of responders on the YBOCS	Number of responders (decrease >35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved)	1 month after treatment
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months	% of improvement compare to baseline	3 months after treatment

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: Bation Remy, MD, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: OCD
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: CSR G01

Plan for Individual participant data (IPD)

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