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Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study

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ClinicalTrials.gov Identifier: NCT03265015
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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

Other: Transcranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas.

Active Comparator: iTBS
Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Behavioral: Habit Override Practice
Computerized "brain training" to provide practice in overriding avoidance habits.

Other: Transcranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas.




Primary Outcome Measures :
  1. functional Magnetic Resonance Imaging (fMRI) [ Time Frame: 10-60min ]
    Brain activation and connectivity in target region


Secondary Outcome Measures :
  1. Quantity of compulsive behaviors in response to laboratory triggers [ Time Frame: 90min-1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: # of repetitions of compulsive behavior

  2. Duration of compulsive behaviors in response to laboratory triggers [ Time Frame: 90min-1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance

  3. Intensity of urges to perform compulsive behaviors in response to laboratory triggers [ Time Frame: 90min-1 week ]
    Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity

  4. Number of habitual responses made following cue devaluation [ Time Frame: 90min-1 week ]
    Custom-made behavioral measure of ability to override learned avoidance-of-shock habits using laboratory task.

  5. Goal-directed cognition [ Time Frame: 90min-1 week ]
    Neuropsychological test of flexible goal-directed cognition

  6. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 1 week ]
    Clinician-administered measurement of obsessions and compulsions

  7. Mood and Anxiety Symptoms Questionnaire [ Time Frame: 1 week ]
    Self-report measure of depression, anxiety, and general distress

  8. Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: 1 week ]
    Self-report measure of obsessions and compulsions



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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)

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): NCT03265015


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
University of Pittsburgh

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Responsible Party: Rebecca Price, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03265015     History of Changes
Other Study ID Numbers: R21MH112770 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.

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