CompletedNCT03265015Updated Aug 16, 2022

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

An interventional study of Habit Override Practice and Transcranial Magnetic Stimulation in Compulsive Behavior and Obsessive-Compulsive Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 78
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Compulsive Behavior
Obsessive-Compulsive Disorder

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Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: 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

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):
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
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)

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 78 participants (actual)

Study arms

Experimental
cTBS
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
Behavioral: Habit Override Practice · Other: Transcranial Magnetic Stimulation
Active comparator
iTBS
Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Behavioral: Habit Override Practice · Other: Transcranial Magnetic Stimulation

Interventions

BehavioralHabit Override Practice
Computerized "brain training" to provide practice in overriding avoidance habits.
OtherTranscranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas.

What researchers measure

Primary outcomes

functional Magnetic Resonance Imaging (fMRI)
Brain activation in target region
Time frame: 10-60min

Secondary outcomes

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
Time frame: 90min-1 week
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
Time frame: 90min-1 week
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
Time frame: 90min-1 week
Two-step task
Neuropsychological test of flexible goal-directed cognition
Time frame: 90min-1 week
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinician-administered measurement of obsessions and compulsions
Time frame: 1 week
WHO Disability Assessment Scale 2.0
Self-report measure of general functioning and disability
Time frame: 1 week
Obsessive Compulsive Inventory-Revised (OCI-R)
Self-report measure of obsessions and compulsions
Time frame: 1 week
Habit override task
Percentage of correct responses to each stimulus (0-100%; higher score=better performance)
Time frame: 1 week

Study locations

1 site

Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

Brown VM, Gillan CM, Renard M, Kaskie R, Degutis M, Wears A, Siegle GJ, Ferrarelli F, Ahmari SE, Price RB. A double-blind study assessing the impact of orbitofrontal theta burst stimulation on goal-directed behavior. J Psychopathol Clin Sci. 2022 Apr;131(3):287-300. doi: 10.1037/abn0000733. Epub 2022 Feb 7. PubMed 35230864 ↗

Individual participant data

Plan to share: Yes — We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.

Registry details

Key details

Study ID: NCT03265015
Lead sponsor: University of Pittsburgh
Collaborators: National Institute of Mental Health (NIMH)
Responsible party: Rebecca Price (Assistant Professor of Psychiatry, University of Pittsburgh) — Principal investigator
First posted: Aug 29, 2017
Start date: Sep 15, 2017
Primary completion: Mar 30, 2020
Completion: Mar 30, 2020
Last update: Aug 16, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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