Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation

NCT ID: NCT02704117

Last Updated: 2023-12-14

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2024-02-29

Brief Summary

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The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.

Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.

Group Type EXPERIMENTAL

Transcranial Magentic Stimulation

Intervention Type DEVICE

This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks

Interventions

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Transcranial Magentic Stimulation

This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks

Intervention Type DEVICE

Other Intervention Names

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Continuous Theta Burst Stimulation (cTBS)

Eligibility Criteria

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Inclusion Criteria

* Current primary OCD diagnosis and current Y-BOCS total score of ≥16
* 18-70 years of age
* Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
* No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
* Ongoing psychotherapy allowed if already established for three months or more before study entry

Exclusion Criteria

* History of primary psychotic disorder or bipolar disorder
* Present acute suicidality
* History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
* Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
* Premorbid intelligence quotient (IQ) estimate \< 80
* Visual disturbance (\<20/40 Snellen visual acuity, corrected)
* Current, or alcohol or illicit substance abuse/dependence in the last 3 months
* Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
* Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
* Current psychotic symptoms
* An increased risk of seizure, determined by history
* Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (\> 4 mg/day of clonazepam or equivalent)
* Predominant hoarding symptoms
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Puerto Rico

OTHER

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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P50MH106435

Identifier Type: NIH

Identifier Source: org_study_id

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