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Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

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ClinicalTrials.gov Identifier: NCT04580043
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Compulsive Behavior Obsessive-Compulsive Disorder Behavioral: Habit Override Practice Device: Transcranial Magnetic Stimulation Behavioral: Sham Training Device: Sham Transcranial Magnetic Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : January 2, 2026
Estimated Study Completion Date : January 2, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: cTBS + Habit Override Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
 Behavioral: Habit Override Practice
Computerized "brain training" to provide practice in overriding avoidance habits.

Device: Transcranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Other Name: cTBS
Active Comparator: Sham TBS + Habit Override Training
Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
 Behavioral: Habit Override Practice
Computerized "brain training" to provide practice in overriding avoidance habits.

Device: Sham Transcranial Magnetic Stimulation
Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Other Name: Sham cTBS
Active Comparator: cTBS + Sham Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
 Device: Transcranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Other Name: cTBS

Behavioral: Sham Training
Computer-based task practice in a non-active/inert task.
Sham Comparator: Sham TBS + Sham Training
Sham Transcranial Magnetic Stimulation, paired with Sham Training.
 Behavioral: Sham Training
Computer-based task practice in a non-active/inert task.

Device: Sham Transcranial Magnetic Stimulation
Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Other Name: Sham cTBS


Outcome Measures
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Primary Outcome Measures :
  1. Brain activation in target region [ Time Frame: 10-60min post-intervention ]
    Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)

  2. Effort to resist compulsive behaviors in response to laboratory triggers [ Time Frame: 60min post-intervention ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)

  3. Duration of compulsive behaviors in response to laboratory triggers [ Time Frame: 60min post-intervention ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)

  4. Intensity of urges to perform compulsive behaviors in response to laboratory triggers [ Time Frame: 60min post-intervention ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)


Secondary Outcome Measures :
  1. Goal-directed cognition [ Time Frame: 90min-1 week ]
    Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)

  2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 1 week ]
    Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)

  3. WHO Disability Assessment Scale 2.0 [ Time Frame: 1 week ]
    Self-report measure of general functioning and disability (0-100; higher score=worse outcome)

  4. Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: 1 week ]
    Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)

  5. Effort to resist compulsive behaviors in response to laboratory triggers [ Time Frame: 1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)

  6. Duration of compulsive behaviors in response to laboratory triggers [ Time Frame: 1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)

  7. Intensity of urges to perform compulsive behaviors in response to laboratory triggers [ Time Frame: 1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)

  8. Brain activation in target region [ Time Frame: 1 week ]
    Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580043


Contacts
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Contact: Rebecca Price, PhD 4126486445 canlab@pitt.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rebecca Price, PhD    412-648-6445    canlab@pitt.edu   
Sponsors and Collaborators
Rebecca Price
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rebecca B Price, PhD University of Pittsburgh
More Information
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Responsible Party: Rebecca Price, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04580043    
Other Study ID Numbers: STUDY19090219 (Part 2)
R01MH124707 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Compulsive Behavior
Mental Disorders
Anxiety Disorders
Impulsive Behavior