Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

NCT ID: NCT04580043

Last Updated: 2026-01-08

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

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2025-12-15

Brief Summary

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This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.

Detailed Description

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Conditions

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Compulsive Behavior Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cTBS + Habit Override Training

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.

Group Type EXPERIMENTAL

Habit Override Practice

Intervention Type BEHAVIORAL

Computerized "brain training" to provide practice in overriding avoidance habits.

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Sham TBS + Habit Override Training

Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.

Group Type ACTIVE_COMPARATOR

Habit Override Practice

Intervention Type BEHAVIORAL

Computerized "brain training" to provide practice in overriding avoidance habits.

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

cTBS + Sham Training

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Sham Training

Intervention Type BEHAVIORAL

Computer-based task practice in a non-active/inert task.

Sham TBS + Sham Training

Sham Transcranial Magnetic Stimulation, paired with Sham Training.

Group Type SHAM_COMPARATOR

Sham Training

Intervention Type BEHAVIORAL

Computer-based task practice in a non-active/inert task.

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Interventions

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Habit Override Practice

Computerized "brain training" to provide practice in overriding avoidance habits.

Intervention Type BEHAVIORAL

Transcranial Magnetic Stimulation

Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Intervention Type DEVICE

Sham Training

Computer-based task practice in a non-active/inert task.

Intervention Type BEHAVIORAL

Sham Transcranial Magnetic Stimulation

Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Intervention Type DEVICE

Other Intervention Names

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cTBS Sham cTBS

Eligibility Criteria

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Inclusion Criteria

Participants will:

1. Be between the ages of 18 and 60 years
2. Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
3. Agree to video taping of structured clinical interview
4. Report that they will reside in the Pittsburgh area for at least 5 weeks

2. Medical contraindications for Transcranial Magnetic Stimulation (TMS):

1. Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
2. Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
3. Pregnancy
4. Metallic implants in body or other devices that may be affected by magnetic field
5. Significant heart disease or cerebrovascular disease
6. Medications with strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)
3. Acute suicidality or other psychiatric crises requiring treatment escalation
4. Changes made to treatment regimen within 4 weeks of baseline assessment
5. Reading level \<6th grade as per participant self-report
6. Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, opiates, amphetamines, and barbiturates)
7. Presence of movement disorder or tics affecting manual responses
8. Inability to read text from 2 feet away (corrective lenses allowed)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rebecca Price

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Price

Associate Professor of Psychiatry

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rebecca B Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH124707

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19090219 (Part 2)

Identifier Type: -

Identifier Source: org_study_id

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