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

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: sham rTMS; Device: rTMS

• 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

Arm && Interventions

Group	Intervention	Description
Healthy Control, Sham TMS	sham rTMS	Healthy control participants who receive sham rTMS
Healthy Control, Active TMS (1 session)	rTMS	Healthy control participants who receive 1 session of active, open-label rTMS
Healthy Control, Active TMS (3 sessions)	rTMS	Healthy control participants who receive 3 sessions of active, open-label rTMS
OCD, Sham TMS	sham rTMS	Participants with OCD who receive sham rTMS
OCD, Active TMS	rTMS	Participants with OCD who receive active rTMS
OCD, Active TMS (3 session)	rTMS	Participants with OCD who receive 3 sessions of active, open-label rTMS
Healthy Control, Active TMS	rTMS	Healthy control participants who receive active rTMS

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