rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

A Multicentre, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy, Safety, and Clinical Outcomes of Low Frequency, Repetitive Transcranial Magnetic Stimulation (Over Supplementary Motor Area (SMA) Applied Bilaterally and Simultaneously) Versus Sham (Placebo rTMS) Treatment for 6 Weeks, When Added to a Stable Pharmacotherapy in Subjects With Obsessive Compulsive Disorder (OCD).

Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Device: repetitive transcranial magnetic stimulation; Device: sham (placebo)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Military Medical Academy
• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care, Mental Health Services
• Turkey
  • Izmir, Turkey
    • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed patient informed consent;
• primary obsessive compulsive disorder;
• YBOCS score at least 20;
• males/females 18-65yrs;
• treated with adequate dose of SSRI at least 8 weeks at some stage of illness;
• currently using adequate, stable dose of SSRI at least 4 weeks but not responding.

Exclusion Criteria:

• schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)>18, substance/alcohol dependence within last 6 months;
• severe axis II;
• suicidal score>=6 on MINI;
• metallic implant in cranium;
• severe/unstable medical conditions;
• not responding to ECT or had TMS in last 6 months;
• history epilepsy;
• neurological disorder leading to increased intracranial pressure;
• severe cardiac disorder/intracardiac lines, pacemakers;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: repetitive transcranial magnetic stimulation; 6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.; Other Names: rTMS machine (MagPro, Medtronic)
Placebo Comparator: 2	Device: sham (placebo); Sham treatment will mimic active treatment mentioned above.; Other Names: rTMS machine (MagPro, Medtronic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale (YBOCS)	pre, week 1, 2, 4, 6, 8, 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression	pre, week 1, 2, 4, 6, 8, 12
Hamilton Depression Rating Scale-21(HDRS)	pre, week 1, 2, 4, 6, 8, 12
Pittsburgh Sleep Quality Index (PSQI)	pre, week 1, 2, 4, 6, 8, 12
Hamilton Anxiety Rating Scale (HARS)	pre, week 1, 2, 4, 6, 8, 12
SF-36 QOLS version (1)	pre, week 1, 2, 4, 6, 8, 12
Visual Analogue Scale	pre, week 1, 2, 4, 6, 8, 12

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Dokuz Eylul University; Military Medical Academy
• Investigators: Study Chair: Roumen Milev, MD, Queen's University

Publications and helpful links

General Publications

• Hawken ER, Dilkov D, Kaludiev E, Simek S, Zhang F, Milev R. Transcranial Magnetic Stimulation of the Supplementary Motor Area in the Treatment of Obsessive-Compulsive Disorder: A Multi-Site Study. Int J Mol Sci. 2016 Mar 22;17(3):420. doi: 10.3390/ijms17030420.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: psiy-266-07