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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: rTMS; Device: sham rTMS

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCD, Active TMS; Participants with OCD who receive active rTMS	Device: rTMS; 1-Hz rTMS targeting frontal pole
Sham Comparator: OCD, Sham TMS; Participants with OCD who receive sham rTMS	Device: sham rTMS; sham rTMS targeting frontal pole
Other: Healthy Control, Active TMS; Healthy control participants who receive active rTMS	Device: rTMS; 1-Hz rTMS targeting frontal pole
Other: Healthy Control, Sham TMS; Healthy control participants who receive sham rTMS	Device: sham rTMS; sham rTMS targeting frontal pole
Other: Healthy Control, Active TMS (1 session); Healthy control participants who receive 1 session of active, open-label rTMS	Device: rTMS; 1-Hz rTMS targeting frontal pole
Other: Healthy Control, Active TMS (3 sessions); Healthy control participants who receive 3 sessions of active, open-label rTMS	Device: rTMS; 1-Hz rTMS targeting frontal pole
Other: OCD, Active TMS (3 session); Participants with OCD who receive 3 sessions of active, open-label rTMS	Device: rTMS; 1-Hz rTMS targeting frontal pole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting-state functional connectivity with ventral striatum	Resting-state functional connectivity with ventral striatum (assessed via fMRI)	Before rTMS and approximately 1 day following open-label rTMS
Resting-state functional connectivity with dorsal striatum	Resting-state functional connectivity with dorsal striatum (assessed via fMRI)	Before rTMS and approximately 1 day following open-label rTMS
Cognitive flexibility task performance	Behavioral performance on a cognitive flexibility task (% trials correct)	Before rTMS and approximately 1 day following open-label rTMS

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in regional activation in orbitofrontal cortex	Change in task-based regional activation (assessed via functional magnetic resonance imaging; fMRI) in orbitofrontal cortex	Before rTMS and within 30 minutes immediately following rTMS
Change in regional activation in dorsolateral prefrontal cortex	Change in task-based regional activation (assessed via fMRI) in dorsolateral prefrontal cortex	Before rTMS and within 30 minutes immediately following rTMS
Change in regional activation in anterior cingulate cortex	Change in task-based regional activation (assessed via fMRI) in anterior cingulate cortex	Before rTMS and within 30 minutes immediately following rTMS
Resting-state functional connectivity with ventral striatum	Resting-state functional connectivity with ventral striatum (assessed via fMRI)	Before rTMS and within 30 minutes immediately following rTMS
Resting-state functional connectivity with dorsal striatum	Resting-state functional connectivity with dorsal striatum (assessed via fMRI)	Before rTMS and within 30 minutes immediately following rTMS
Cognitive flexibility task performance	Behavioral performance on a cognitive flexibility task (% trials correct)	Before rTMS and within 30 minutes immediately following rTMS

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Sarah Garnaat, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 1901-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No