- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540305
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
February 27, 2012 updated by: Joaquim Brasil-Neto, University of Brasilia
A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up
This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks.
Randomization was performed according to a computer-generated schedule.
Subjects and scale-rater physician were blind to treatment status of individuals.
Only the rTMS administrator was aware of group allocations.
Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study.
All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs.
Their prescription drugs were continued without change in dosage regimens throughout the study.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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DF
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Brasília, DF, Brazil, 70000-000
- Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18 to 60 years
- diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).
Exclusion Criteria:
- subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
- significant head injury, or of any neurosurgical procedure
- pregnant women
- patients with metal implants or illnesses that prevent attendance to sessions
- patients with a history of seizure or bearing pacemakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcranial Magnetic Stimulation
Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.
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rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil.
Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.
Other Names:
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Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham transcranial magnetic stimulation over the supplementary motor areas.
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The sham treatment was performed using the Neurosoft ® sham coil.
A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex.
This coil looks and sounds like an active coil.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Y-BOCS scale scores relative to baseline
Time Frame: assessments were at baseline, at 2 weeks and at 3 months
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Y-BOCS: Yale-Brown Obsessive-Compulsive Scale
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assessments were at baseline, at 2 weeks and at 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Joaquim Brasil-Neto, MD, PhD, University of Brasilia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.
- Mantovani A, Simpson HB, Fallon BA, Rossi S, Lisanby SH. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2010 Mar;13(2):217-27. doi: 10.1017/S1461145709990435. Epub 2009 Aug 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 15, 2012
First Submitted That Met QC Criteria
February 27, 2012
First Posted (Estimate)
February 28, 2012
Study Record Updates
Last Update Posted (Estimate)
February 28, 2012
Last Update Submitted That Met QC Criteria
February 27, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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