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
2 other identifiers
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedAugust 16, 2022
August 1, 2022
2.5 years
August 18, 2017
August 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
functional Magnetic Resonance Imaging (fMRI)
Brain activation in target region
10-60min
Secondary Outcomes (8)
Effort to resist compulsive behaviors in response to laboratory triggers
90min-1 week
Duration of 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
- +3 more secondary outcomes
Study Arms (2)
cTBS
EXPERIMENTALTranscranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
iTBS
ACTIVE COMPARATORTranscranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Interventions
Computerized "brain training" to provide practice in overriding avoidance habits.
Non-invasive method for temporary, focal stimulation of brain areas.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 35230864DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 29, 2017
Study Start
September 15, 2017
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
August 16, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.