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

December 9, 2022 updated by: Butler Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Before rTMS and approximately 1 day following open-label rTMS
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)
Before rTMS and approximately 1 day following open-label rTMS
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)
Before rTMS and approximately 1 day following open-label rTMS

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in regional activation in orbitofrontal cortex
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
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
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
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
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
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
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
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
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Before rTMS and within 30 minutes immediately following rTMS
Cognitive flexibility task performance
Time Frame: Before rTMS and within 30 minutes immediately following rTMS
Behavioral performance on a cognitive flexibility task (% trials correct)
Before rTMS and within 30 minutes immediately following rTMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Butler Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Garnaat, PhD, Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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