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Clinical Trials/NCT04165577
NCT04165577
Completed
N/A

Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study

Butler Hospital1 site in 1 country68 target enrollmentNovember 15, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Butler Hospital
Enrollment
68
Locations
1
Primary Endpoint
Resting-state functional connectivity with dorsal striatum
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.

Registry
clinicaltrials.gov
Start Date
November 15, 2019
End Date
December 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and
  • right-handed.
  • Inclusion Criteria: Healthy Control group
  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • right-handed.

Exclusion Criteria

  • active problematic substance use;
  • lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature;
  • clinically significant hoarding symptoms;
  • active suicidal or homicidal ideation;
  • significant neurological disease or intracranial pathology;
  • use of medications which increase risk for seizures during TMS;
  • significant or unstable medical disorders or contraindication to TMS or MRI scan.
  • Exclusion Criteria: Healthy Control group
  • current psychiatric diagnosis;
  • lifetime psychosis, bipolar mood disorder, or OCD;

Outcomes

Primary Outcomes

Resting-state functional connectivity with dorsal striatum

Time Frame: Before rTMS and approximately 1 day following open-label rTMS

Resting-state functional connectivity with dorsal striatum (assessed via fMRI)

Cognitive flexibility task performance

Time Frame: Before rTMS and approximately 1 day following open-label rTMS

Behavioral performance on a cognitive flexibility task (% trials correct)

Resting-state functional connectivity with ventral striatum

Time Frame: Before rTMS and approximately 1 day following open-label rTMS

Resting-state functional connectivity with ventral striatum (assessed via fMRI)

Study Sites (1)

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