Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- functional Magnetic Resonance Imaging (fMRI)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
cTBS
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
Intervention: Habit Override Practice (Behavioral)
cTBS
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
Intervention: Transcranial Magnetic Stimulation (Other)
iTBS
Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Intervention: Habit Override Practice (Behavioral)
iTBS
Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Intervention: Transcranial Magnetic Stimulation (Other)
Outcomes
Primary Outcomes
functional Magnetic Resonance Imaging (fMRI)
Time Frame: 10-60min
Brain activation in target region
Secondary Outcomes
- Effort to resist compulsive behaviors in response to laboratory triggers(90min-1 week)
- Intensity of urges to perform compulsive behaviors in response to laboratory triggers(90min-1 week)
- Two-step task(90min-1 week)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(1 week)
- Duration of compulsive behaviors in response to laboratory triggers(90min-1 week)
- WHO Disability Assessment Scale 2.0(1 week)
- Obsessive Compulsive Inventory-Revised (OCI-R)(1 week)
- Habit override task(1 week)
Investigators
Rebecca Price
Assistant Professor of Psychiatry
University of Pittsburgh