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

NCT ID: NCT04165577

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2022-12-02

Brief Summary

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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

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Arms denoted as open-label do not include masking

Study Groups

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OCD, Active TMS

Participants with OCD who receive active rTMS

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

1-Hz rTMS targeting frontal pole

OCD, Sham TMS

Participants with OCD who receive sham rTMS

Group Type SHAM_COMPARATOR

sham rTMS

Intervention Type DEVICE

sham rTMS targeting frontal pole

Healthy Control, Active TMS

Healthy control participants who receive active rTMS

Group Type OTHER

rTMS

Intervention Type DEVICE

1-Hz rTMS targeting frontal pole

Healthy Control, Sham TMS

Healthy control participants who receive sham rTMS

Group Type OTHER

sham rTMS

Intervention Type DEVICE

sham rTMS targeting frontal pole

Healthy Control, Active TMS (1 session)

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

Group Type OTHER

rTMS

Intervention Type DEVICE

1-Hz rTMS targeting frontal pole

Healthy Control, Active TMS (3 sessions)

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

Group Type OTHER

rTMS

Intervention Type DEVICE

1-Hz rTMS targeting frontal pole

OCD, Active TMS (3 session)

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

Group Type OTHER

rTMS

Intervention Type DEVICE

1-Hz rTMS targeting frontal pole

Interventions

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rTMS

1-Hz rTMS targeting frontal pole

Intervention Type DEVICE

sham rTMS

sham rTMS targeting frontal pole

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Garnaat, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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1901-003

Identifier Type: -

Identifier Source: org_study_id