Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01043900
First received: January 5, 2010
Last updated: January 6, 2010
Last verified: September 2009
  Purpose

OCD is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families.

The present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment.

Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Procedure: repetitive transcranial magnetic stimulation (rTMS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham rTMS
Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex
Procedure: repetitive transcranial magnetic stimulation (rTMS)
30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex
Other Name: TMS
Active Comparator: Active rTMS
Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex
Procedure: repetitive transcranial magnetic stimulation (rTMS)
30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex
Other Name: TMS

Detailed Description:

The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.

Side effects include scalp discomfort and mild headache. No anesthesia is required.

Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • resistant OCD patients: maximum 25% reduction in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after at least 3 adequate trials with serotonin reuptake inhibitors (SRI) (including clomipramine) and 20 hours of cognitive behavioral therapy (CBT) or documented intolerance to either treatment.

Exclusion Criteria:

  • metallic cerebral implants
  • history of severe trauma or brain injury
  • organic brain disease
  • severe somatic disease
  • history of drug dependence
  • chronic psychosis
  • present manic state
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043900

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Carlos G Mansur, MD Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Gustavo Mansur, Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
ClinicalTrials.gov Identifier: NCT01043900     History of Changes
Other Study ID Numbers: cgmansur01
Study First Received: January 5, 2010
Last Updated: January 6, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Obsessive-Compulsive Disorder
rTMS
Transcranial Magnetic Stimulation
treatment
randomized controlled trials

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on April 17, 2014