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Completed

NCT Number: NCT04580043

Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

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.

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Key information

Conditions

Compulsive Behavior Anxiety Disorders Behavior Impulsive Behavior Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
  • 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)

Treatment and study plan

Habit Override Practice

Behavioral

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

Transcranial Magnetic Stimulation

Device

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

Other names: cTBS

Sham Training

Behavioral

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

Sham Transcranial Magnetic Stimulation

Device

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

Other names: Sham cTBS

Primary outcomes

  1. Brain activation in target region

    Time frame: 10-60min post-intervention

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

  2. Effort to resist compulsive behaviors in response to laboratory triggers

    Time frame: 60min post-intervention

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

  3. Duration of compulsive behaviors in response to laboratory triggers

    Time frame: 60min post-intervention

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

  4. Intensity of urges to perform compulsive behaviors in response to laboratory triggers

    Time frame: 60min post-intervention

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

Secondary outcomes

  1. Goal-directed cognition

    Time frame: 90min-1 week

    Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)

  2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 1 week

    Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)

  3. WHO Disability Assessment Scale 2.0

    Time frame: 1 week

    Self-report measure of general functioning and disability (0-100; higher score=worse outcome)

  4. Obsessive Compulsive Inventory-Revised (OCI-R)

    Time frame: 1 week

    Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)

  5. Effort to resist compulsive behaviors in response to laboratory triggers

    Time frame: 1 week

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

  6. Duration of compulsive behaviors in response to laboratory triggers

    Time frame: 1 week

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

  7. Intensity of urges to perform compulsive behaviors in response to laboratory triggers

    Time frame: 1 week

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

  8. Brain activation in target region

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Rebecca Price

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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