NCT00616486

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

February 4, 2008

Last Update Submit

December 14, 2015

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Scale (YBOCS)

    pre, week 1, 2, 4, 6, 8, 12

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Device: repetitive transcranial magnetic stimulation

2

PLACEBO COMPARATOR
Device: sham (placebo)

Interventions

repetitive transcranial magnetic stimulationDEVICE

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.

Also known as: rTMS machine (MagPro, Medtronic)
1
sham (placebo)DEVICE

Sham treatment will mimic active treatment mentioned above.

Also known as: rTMS machine (MagPro, Medtronic).
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Military Medical Academy

Sofia, Bulgaria

Location

Providence Care, Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 27011177DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Roumen Milev, MD

    Queen's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

November 1, 2012

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

TU(1)BU(1)CA(1)