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).

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616486

Enrollment

Registered

2008-02-15

Start date

2008-01-31

Completion date

2012-11-30

Last updated

2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Brief summary

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.

Interventions

DEVICErepetitive 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.

DEVICEsham (placebo)

Sham treatment will mimic active treatment mentioned above.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame
SF-36 QOLS version (1)	pre, week 1, 2, 4, 6, 8, 12
Visual Analogue Scale	pre, week 1, 2, 4, 6, 8, 12
Hamilton Anxiety Rating Scale (HARS)	pre, week 1, 2, 4, 6, 8, 12
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

Countries

Bulgaria, Canada, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026