search
Back to results

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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, rTMS, Transcranial Magnetic Stimulation, treatment, randomized controlled trials

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Sham rTMS

    Active rTMS

    Arm Description

    Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex

    Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex

    Outcomes

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2010
    Last Updated
    January 6, 2010
    Sponsor
    University of Sao Paulo General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01043900
    Brief Title
    Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD
    Official Title
    Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder
    Keywords
    Obsessive-Compulsive Disorder, rTMS, Transcranial Magnetic Stimulation, treatment, randomized controlled trials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham rTMS
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex
    Arm Title
    Active rTMS
    Arm Type
    Active Comparator
    Arm Description
    Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex
    Intervention Type
    Procedure
    Intervention Name(s)
    repetitive transcranial magnetic stimulation (rTMS)
    Other Intervention Name(s)
    TMS
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos G Mansur, MD
    Organizational Affiliation
    Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21557884
    Citation
    Mansur CG, Myczkowki ML, de Barros Cabral S, Sartorelli Mdo C, Bellini BB, Dias AM, Bernik MA, Marcolin MA. Placebo effect after prefrontal magnetic stimulation in the treatment of resistant obsessive-compulsive disorder: a randomized controlled trial. Int J Neuropsychopharmacol. 2011 Nov;14(10):1389-97. doi: 10.1017/S1461145711000575. Epub 2011 Apr 18.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs