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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

NCT ID: NCT00616486

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.

2

Group Type PLACEBO_COMPARATOR

sham (placebo)

Intervention Type DEVICE

Sham treatment will mimic active treatment mentioned above.

Interventions

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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.

Intervention Type DEVICE

sham (placebo)

Sham treatment will mimic active treatment mentioned above.

Intervention Type DEVICE

Other Intervention Names

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rTMS machine (MagPro, Medtronic) rTMS machine (MagPro, Medtronic).

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Medical Academy, Bulgaria

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Roumen Milev

Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roumen Milev, MD

Role: STUDY_CHAIR

Queen's University

Locations

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Military Medical Academy

Sofia, , Bulgaria

Site Status

Providence Care, Mental Health Services

Kingston, Ontario, Canada

Site Status

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Bulgaria Canada Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 27011177 (View on PubMed)

Other Identifiers

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psiy-266-07

Identifier Type: -

Identifier Source: org_study_id