Feasibility of Modulating Cognitive Control in OCD
Evaluating Frontal Pole as a Window to Modulation of Cognitive Control in OCD
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current primary DSM-5 OCD diagnosis and current Y-BOCS total score of ≥16 (OCD group, only) or no current diagnosis of an emotional disorder, and no known history of OCD, PTSD, anxiety disorder(s), or recurrent major depressive disorder (Healthy participant group, only)
- 18-60 years of age
- ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
- psychotherapy and/or psychiatric medication use remain stable for 6 weeks prior to study entry
Exclusion Criteria:
- Presence of current psychiatric diagnosis (healthy control group, only)
- active substance use disorder
- history of mania or hypomania, or lifetime presence of significant psychotic symptoms
- active suicidal or homicidal ideation
- use of medications known to reduce seizure threshold (e.g., stimulants)
- organic brain disease or injury representing a contraindication to TMS
- any health problems that would interfere with safe and/or practical study participation, including contraindications to TMS (e.g., seizure disorder, presence of metal hardware that would come in close contact with the discharging coil)
- current pregnancy or planning to become pregnant during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Obsessive-compulsive disorder (OCD)
|
3 consecutive daily sessions of cTBS
|
|
Other: Healthy Adult Participants
|
3 consecutive daily sessions of cTBS
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of enrollment
Time Frame: At study enrollment
|
Percent of screened participants who are determined to be eligible and enrolled.
|
At study enrollment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of visit completion
Time Frame: From enrollment to date of post-TMS study visit (approximately 1 week)
|
Percent (%) of enrolled participants completing each study visit
|
From enrollment to date of post-TMS study visit (approximately 1 week)
|
|
Peak cTBS intensity tolerated
Time Frame: From enrollment to end of TMS sessions (approximately 1 week)
|
Average of peak intensity (up to target intensity) tolerated during cTBS sessions
|
From enrollment to end of TMS sessions (approximately 1 week)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY02003117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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