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

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT04165577
• Lead Sponsor: Butler Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study Start: 2019-11-15
• Study First Posted: 2019-11-18
• Status Verified: 2022-12
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

OCD group

• 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

OCD group

• 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;
• active suicidal or homicidal ideation;
• significant neurological disease or intracranial pathology;
• use of psychiatric medications;
• use of medications which increase risk for seizures during TMS;
• significant or unstable medical disorders or contraindication to TMS or MRI scan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting-state functional connectivity with dorsal striatum	Before rTMS and approximately 1 day following open-label rTMS	Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Cognitive flexibility task performance	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	Before rTMS and approximately 1 day following open-label rTMS	Resting-state functional connectivity with ventral striatum (assessed via fMRI)

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States