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The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
University of Manitoba
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, Transcranial Magnetic Stimulation, Error processing

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed obsessive compulsive disorder
  • Not currently receiving cognitive behavioural therapy
  • Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria:

  • History of psychotic episodes
  • History of neurological illness
  • Previous head injury
  • Active alcohol or substance abuse
  • History of seizure disorders
  • Currently pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients

    Healthy Control Subjects

    Arm Description

    Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder

    One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals

    Outcomes

    Primary Outcome Measures

    Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
    Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.

    Secondary Outcome Measures

    Change in Post-error Slowing
    Post-error slowing (PES) is the difference in response time on trials following an error to trials following a correct response. Higher numbers indicate more post-error slowing (i.e. longer response times following an error trial compared to following a correct trial). The outcome measure is the change in PES from baseline to following one session of rTMS.

    Full Information

    First Posted
    September 2, 2015
    Last Updated
    August 28, 2020
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02541812
    Brief Title
    The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study
    Official Title
    The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder (OCD), a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.
    Detailed Description
    A battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (ACC) function, will be administered before and after one session of rTMS in all participants. The first neurocognitive session will be administered in a separate day from the rTMS session. The second neurocognitive session will be performed immediately after rTMS and in the same day. Participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition. The rTMS paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded a high resolution MRI of each subjects' brain. OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the same protocol described above.

    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, Transcranial Magnetic Stimulation, Error processing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients
    Arm Type
    Experimental
    Arm Description
    Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder
    Arm Title
    Healthy Control Subjects
    Arm Type
    Active Comparator
    Arm Description
    One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial Magnetic Stimulation
    Intervention Description
    A non-invasive method for brain stimulation
    Primary Outcome Measure Information:
    Title
    Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
    Description
    Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.
    Time Frame
    Recordings: baseline; after two weeks of rTMS
    Secondary Outcome Measure Information:
    Title
    Change in Post-error Slowing
    Description
    Post-error slowing (PES) is the difference in response time on trials following an error to trials following a correct response. Higher numbers indicate more post-error slowing (i.e. longer response times following an error trial compared to following a correct trial). The outcome measure is the change in PES from baseline to following one session of rTMS.
    Time Frame
    Recordings: baseline; after one session of rTMS

    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: Diagnosed obsessive compulsive disorder Not currently receiving cognitive behavioural therapy Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI) Exclusion Criteria: History of psychotic episodes History of neurological illness Previous head injury Active alcohol or substance abuse History of seizure disorders Currently pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mandana Modirrousta, MD PhD FRCPC
    Organizational Affiliation
    University of Manitoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26453446
    Citation
    Modirrousta M, Meek BP, Sareen J, Enns MW. Impaired trial-by-trial adjustment of cognitive control in obsessive compulsive disorder improves after deep repetitive transcranial magnetic stimulation. BMC Neurosci. 2015 Oct 9;16:63. doi: 10.1186/s12868-015-0205-z.
    Results Reference
    derived

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    The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study

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