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

NCT04165577 | Completed FDA Device

• 1 other identifier: 1901-003
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in regional activation in orbitofrontal cortex

  Before rTMS and within 30 minutes immediately following rTMS

• Change in regional activation in dorsolateral prefrontal cortex

  Before rTMS and within 30 minutes immediately following rTMS

• Change in regional activation in anterior cingulate cortex

  Before rTMS and within 30 minutes immediately following rTMS

Study Arms (7)

OCD, Active TMS

EXPERIMENTAL

Participants with OCD who receive active rTMS

Device: rTMS

OCD, Sham TMS

SHAM COMPARATOR

Participants with OCD who receive sham rTMS

Device: sham rTMS

Healthy Control, Active TMS

OTHER

Healthy control participants who receive active rTMS

Device: rTMS

Healthy Control, Sham TMS

OTHER

Healthy control participants who receive sham rTMS

Device: sham rTMS

Healthy Control, Active TMS (1 session)

OTHER

Healthy control participants who receive 1 session of active, open-label rTMS

Device: rTMS

Healthy Control, Active TMS (3 sessions)

OTHER

Healthy control participants who receive 3 sessions of active, open-label rTMS

Device: rTMS

OCD, Active TMS (3 session)

OTHER

Participants with OCD who receive 3 sessions of active, open-label rTMS

Device: rTMS

Interventions

rTMS DEVICE

1-Hz rTMS targeting frontal pole

Healthy Control, Active TMS; Healthy Control, Active TMS (1 session); Healthy Control, Active TMS (3 sessions); OCD, Active TMS; OCD, Active TMS (3 session)

sham rTMS DEVICE

sham rTMS targeting frontal pole

Healthy Control, Sham TMS; OCD, Sham TMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
• 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.
• years of age;
• ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
• right-handed.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sarah Garnaat, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Arms denoted as open-label do not include masking
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: November 15, 2019
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (1)