Back to resultsNeurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation
Primary Purpose
Obsessive-Compulsive Disorder
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magentic Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Current primary OCD diagnosis and current Y-BOCS total score of ≥16
- 18-70 years of age
- Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
- No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
- Ongoing psychotherapy allowed if already established for three months or more before study entry
Exclusion Criteria:
- History of primary psychotic disorder or bipolar disorder
- Present acute suicidality
- History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
- Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
- Premorbid intelligence quotient (IQ) estimate < 80
- Visual disturbance (<20/40 Snellen visual acuity, corrected)
- Current, or alcohol or illicit substance abuse/dependence in the last 3 months
- Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
- Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
- Current psychotic symptoms
- An increased risk of seizure, determined by history
- Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)
- Predominant hoarding symptoms
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial Magnetic Stimulation
Arm Description
Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.
Outcomes
Primary Outcome Measures
Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)
Secondary Outcome Measures
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Full Information
NCT ID
NCT02704117
First Posted
February 29, 2016
Last Updated
October 2, 2023
Sponsor
Butler Hospital
Collaborators
University of Rochester, Harvard University, University of Pittsburgh, University of Puerto Rico
1. Study Identification
Unique Protocol Identification Number
NCT02704117
Brief Title
Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation
Official Title
Neurocircuitry of OCD: Effects Of Modulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
University of Rochester, Harvard University, University of Pittsburgh, University of Puerto Rico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.
Intervention Type
Device
Intervention Name(s)
Transcranial Magentic Stimulation
Other Intervention Name(s)
Continuous Theta Burst Stimulation (cTBS)
Intervention Description
This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks
Primary Outcome Measure Information:
Title
Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current primary OCD diagnosis and current Y-BOCS total score of ≥16
18-70 years of age
Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
Ongoing psychotherapy allowed if already established for three months or more before study entry
Exclusion Criteria:
History of primary psychotic disorder or bipolar disorder
Present acute suicidality
History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
Premorbid intelligence quotient (IQ) estimate < 80
Visual disturbance (<20/40 Snellen visual acuity, corrected)
Current, or alcohol or illicit substance abuse/dependence in the last 3 months
Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
Current psychotic symptoms
An increased risk of seizure, determined by history
Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)
Predominant hoarding symptoms
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Links:
URL
https://butler.org/stim
Description
Related Info
Learn more about this trial
Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation
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