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Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04580043
Enrollment
203
Registered
2020-10-08
Start date
2020-12-28
Completion date
2025-12-15
Last updated
2026-02-10

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 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

BEHAVIORALSham Training

Computer-based task practice in a non-active/inert task.

DEVICESham Transcranial Magnetic Stimulation

Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Computerized "brain training" to provide practice in overriding avoidance habits.

DEVICETranscranial Magnetic Stimulation

Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Sponsors

Rebecca Price
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

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 60 Years
Healthy volunteers
No

Inclusion criteria

Participants will: 1. Be between the ages of 18 and 60 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 strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants) 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 as per participant self-report 6. Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, 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
Intensity of urges to perform compulsive behaviors in response to laboratory triggers60min post-interventionCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
Brain activation in target region10-60min post-interventionMean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Effort to resist compulsive behaviors in response to laboratory triggers60min post-interventionCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
Duration of compulsive behaviors in response to laboratory triggers60min post-interventionCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)

Secondary

MeasureTime frameDescription
Goal-directed cognition90min-1 weekNeuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)1 weekClinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
WHO Disability Assessment Scale 2.01 weekSelf-report measure of general functioning and disability (0-100; higher score=worse outcome)
Obsessive Compulsive Inventory-Revised (OCI-R)1 weekSelf-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
Effort to resist compulsive behaviors in response to laboratory triggers1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
Duration of compulsive behaviors in response to laboratory triggers1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)
Intensity of urges to perform compulsive behaviors in response to laboratory triggers1 weekCustom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
Brain activation in target region1 weekMean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRebecca B Price, PhD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026