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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
01

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.

02

Conditions studied

  • Compulsive Behavior
  • Obsessive-Compulsive Disorder
03

In context

Compulsive Behavior

30 studies on the registry are indexed under Compulsive Behavior; 6 are open to participants now.

This study's enrollment of 78 is above the median of 50 across 27 interventional studies indexed under Compulsive Behavior.

Browse Compulsive Behavior studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Browse University of Pittsburgh studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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.

06

What researchers measure

Primary outcomes

  1. functional Magnetic Resonance Imaging (fMRI)

    Brain activation in target region

    Time frame: 10-60min

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Two-step task

    Neuropsychological test of flexible goal-directed cognition

    Time frame: 90min-1 week

  5. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Clinician-administered measurement of obsessions and compulsions

    Time frame: 1 week

  6. WHO Disability Assessment Scale 2.0

    Self-report measure of general functioning and disability

    Time frame: 1 week

  7. Obsessive Compulsive Inventory-Revised (OCI-R)

    Self-report measure of obsessions and compulsions

    Time frame: 1 week

  8. Habit override task

    Percentage of correct responses to each stimulus (0-100%; higher score=better performance)

    Time frame: 1 week

07

Study locations

1 site
  • Western Psychiatric Institute and Clinic
    Pittsburgh, Pennsylvania 15213, United States
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Mar 2020, 30 months.

Of 14 interventional studies with no phase under Compulsive Behavior, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 30 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Aug 29, 2017
StartActual
Sep 15, 2017
Primary completionActual
Mar 30, 2020
CompletionActual
Mar 30, 2020
Last update
Aug 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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