Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

NCT04580043 | Completed FDA Device

• 2 other identifiers: STUDY19090219 (Part 2)R01MH124707
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Compulsive Behavior; Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (4)

• Brain activation in target region

  Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)

  10-60min post-intervention

• Effort to resist compulsive behaviors in response to laboratory triggers

  Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)

  60min post-intervention

• Duration of compulsive behaviors in response to laboratory triggers

  Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)

  60min post-intervention

• Intensity of urges to perform compulsive behaviors in response to laboratory triggers

  Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)

  60min post-intervention

Secondary Outcomes (8)

• Goal-directed cognition

  90min-1 week

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  1 week

• WHO Disability Assessment Scale 2.0

  1 week

• Obsessive Compulsive Inventory-Revised (OCI-R)

  1 week

• Effort to resist compulsive behaviors in response to laboratory triggers

  1 week

Study Arms (4)

cTBS + Habit Override Training

EXPERIMENTAL

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

Behavioral: Habit Override Practice; Device: Transcranial Magnetic Stimulation

Sham TBS + Habit Override Training

ACTIVE COMPARATOR

Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.

Behavioral: Habit Override Practice; Device: Sham Transcranial Magnetic Stimulation

cTBS + Sham Training

ACTIVE COMPARATOR

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

Device: Transcranial Magnetic Stimulation; Behavioral: Sham Training

Sham TBS + Sham Training

SHAM COMPARATOR

Sham Transcranial Magnetic Stimulation, paired with Sham Training.

Behavioral: Sham Training; Device: Sham Transcranial Magnetic Stimulation

Interventions

Habit Override Practice BEHAVIORAL

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

Sham TBS + Habit Override Training; cTBS + Habit Override Training

Transcranial Magnetic Stimulation DEVICE

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

Also known as: cTBS

cTBS + Habit Override Training; cTBS + Sham Training

Sham Training BEHAVIORAL

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

Sham TBS + Sham Training; cTBS + Sham Training

Sham Transcranial Magnetic Stimulation DEVICE

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

Also known as: Sham cTBS

Sham TBS + Habit Override Training; Sham TBS + Sham Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medical contraindications for Transcranial Magnetic Stimulation (TMS):
• 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)
• Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
• Pregnancy
• Metallic implants in body or other devices that may be affected by magnetic field
• Significant heart disease or cerebrovascular disease
• Medications with strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)
• Acute suicidality or other psychiatric crises requiring treatment escalation
• Changes made to treatment regimen within 4 weeks of baseline assessment
• Reading level \<6th grade as per participant self-report
• 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)
• Presence of movement disorder or tics affecting manual responses
• Inability to read text from 2 feet away (corrective lenses allowed)

Sponsors & Collaborators

• Rebecca Price: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Compulsive Behavior; Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Impulsive Behavior; Behavior; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Rebecca B Price, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: December 28, 2020
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)