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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 : January 7, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 1, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE December 28, 2020
Estimated Primary Completion Date January 2, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • Goal-directed cognition [ Time Frame: 90min-1 week ]
    Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
  • 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)
  • WHO Disability Assessment Scale 2.0 [ Time Frame: 1 week ]
    Self-report measure of general functioning and disability (0-100; higher score=worse outcome)
  • Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: 1 week ]
    Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
  • 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)
  • 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)
  • 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)
  • Brain activation in target region [ Time Frame: 1 week ]
    Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors
Official Title  ICMJE Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Compulsive Behavior
  • Obsessive-Compulsive Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: cTBS + Habit Override Training
    Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
    Interventions:
    • Behavioral: Habit Override Practice
    • Device: Transcranial Magnetic Stimulation
  • Active Comparator: Sham TBS + Habit Override Training
    Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
    Interventions:
    • Behavioral: Habit Override Practice
    • Device: Sham Transcranial Magnetic Stimulation
  • Active Comparator: cTBS + Sham Training
    Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
    Interventions:
    • Device: Transcranial Magnetic Stimulation
    • Behavioral: Sham Training
  • Sham Comparator: Sham TBS + Sham Training
    Sham Transcranial Magnetic Stimulation, paired with Sham Training.
    Interventions:
    • Behavioral: Sham Training
    • Device: Sham Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2, 2027
Estimated Primary Completion Date January 2, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Price, PhD 4126486445 canlab@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04580043
Other Study ID Numbers  ICMJE MOD19090219-002
R01MH124707 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rebecca Price, University of Pittsburgh
Study Sponsor  ICMJE Rebecca Price
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Rebecca B Price, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP