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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03265015
Enrollment
78
Registered
2017-08-29
Start date
2017-09-15
Completion date
2020-03-30
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compulsive Behavior, Obsessive-Compulsive Disorder

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.

Interventions

Computerized brain training to provide practice in overriding avoidance habits.

OTHERTranscranial Magnetic Stimulation

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Participants will: 1. Be between the ages of 18 and 55 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

Exclusion criteria

1. 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. 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 seizure threshold lowering potential, e.g., clomipramine, Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine 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 6. 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) 7. Presence of movement disorder or tics affecting manual responses 8. Inability to read text from 2 feet away (corrective lenses allowed)

Design outcomes

Primary

MeasureTime frameDescription
functional Magnetic Resonance Imaging (fMRI)10-60minBrain activation in target region

Secondary

MeasureTime frameDescription
Duration of compulsive behaviors in response to laboratory triggers90min-1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance
Intensity of urges to perform compulsive behaviors in response to laboratory triggers90min-1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity
Two-step task90min-1 weekNeuropsychological test of flexible goal-directed cognition
Effort to resist compulsive behaviors in response to laboratory triggers90min-1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist
WHO Disability Assessment Scale 2.01 weekSelf-report measure of general functioning and disability
Obsessive Compulsive Inventory-Revised (OCI-R)1 weekSelf-report measure of obsessions and compulsions
Habit override task1 weekPercentage of correct responses to each stimulus (0-100%; higher score=better performance)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)1 weekClinician-administered measurement of obsessions and compulsions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026