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
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
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
NCT ID
NCT02541812
First Posted
September 2, 2015
Last Updated
August 28, 2020
Sponsor
University of Manitoba
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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