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Completed

NCT Number: NCT03265015

Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study

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 in two directions (up or down) 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

Age range

18 year–55 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 55 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 seizure threshold lowering potential, e.g., clomipramine, Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine
  • Acute suicidality or other psychiatric crises requiring treatment escalation
  • Changes made to treatment regimen within 4 weeks of baseline assessment
  • Reading level <6th grade
  • Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current use of mood altering drugs such as cocaine, cannabis or marijuana, 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

Other

Non-invasive method for temporary, focal stimulation of brain areas.

Primary outcomes

  1. functional Magnetic Resonance Imaging (fMRI)

    Time frame: 10-60min

    Brain activation in target region

Secondary outcomes

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

    Time frame: 90min-1 week

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

  2. Duration of compulsive behaviors in response to laboratory triggers

    Time frame: 90min-1 week

    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance

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

    Time frame: 90min-1 week

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

  4. Two-step task

    Time frame: 90min-1 week

    Neuropsychological test of flexible goal-directed cognition

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

    Time frame: 1 week

    Clinician-administered measurement of obsessions and compulsions

  6. WHO Disability Assessment Scale 2.0

    Time frame: 1 week

    Self-report measure of general functioning and disability

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

    Time frame: 1 week

    Self-report measure of obsessions and compulsions

  8. Habit override task

    Time frame: 1 week

    Percentage of correct responses to each stimulus (0-100%; higher score=better performance)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Aug 16, 2022

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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