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

Primary Purpose

Compulsive Behavior, Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit Override Practice
Transcranial Magnetic Stimulation
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Compulsive Behavior

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cTBS

iTBS

Arm Description

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.

Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.

Outcomes

Primary Outcome Measures

functional Magnetic Resonance Imaging (fMRI)
Brain activation in target region

Secondary Outcome Measures

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
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
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
Two-step task
Neuropsychological test of flexible goal-directed cognition
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinician-administered measurement of obsessions and compulsions
WHO Disability Assessment Scale 2.0
Self-report measure of general functioning and disability
Obsessive Compulsive Inventory-Revised (OCI-R)
Self-report measure of obsessions and compulsions
Habit override task
Percentage of correct responses to each stimulus (0-100%; higher score=better performance)

Full Information

First Posted
August 18, 2017
Last Updated
August 14, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03265015
Brief Title
Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study
Official Title
Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compulsive Behavior, Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cTBS
Arm Type
Experimental
Arm Description
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
Arm Title
iTBS
Arm Type
Active Comparator
Arm Description
Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
Intervention Type
Behavioral
Intervention Name(s)
Habit Override Practice
Intervention Description
Computerized "brain training" to provide practice in overriding avoidance habits.
Intervention Type
Other
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Non-invasive method for temporary, focal stimulation of brain areas.
Primary Outcome Measure Information:
Title
functional Magnetic Resonance Imaging (fMRI)
Description
Brain activation in target region
Time Frame
10-60min
Secondary Outcome Measure Information:
Title
Effort to resist compulsive behaviors in response to laboratory triggers
Description
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
Title
Duration of compulsive behaviors in response to laboratory triggers
Description
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
Title
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Description
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity
Time Frame
90min-1 week
Title
Two-step task
Description
Neuropsychological test of flexible goal-directed cognition
Time Frame
90min-1 week
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Clinician-administered measurement of obsessions and compulsions
Time Frame
1 week
Title
WHO Disability Assessment Scale 2.0
Description
Self-report measure of general functioning and disability
Time Frame
1 week
Title
Obsessive Compulsive Inventory-Revised (OCI-R)
Description
Self-report measure of obsessions and compulsions
Time Frame
1 week
Title
Habit override task
Description
Percentage of correct responses to each stimulus (0-100%; higher score=better performance)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will: Be between the ages of 18 and 55 years Endorse problematic compulsive behaviors, per self-report and clinician-administered measures. Agree to video taping of structured clinical interview Report that they will reside in the Pittsburgh area for at least 5 weeks Exclusion Criteria: 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. Medical contraindications for Transcranial Magnetic Stimulation (TMS): 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) Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy Pregnancy Metallic implants in body or other devices that may be affected by magnetic field Significant heart disease or cerebrovascular disease Medications with seizure threshold lowering potential, e.g., clomipramine, Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine Acute suicidality or other psychiatric crises requiring treatment escalation Changes made to treatment regimen within 4 weeks of baseline assessment Reading level <6th grade 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) Presence of movement disorder or tics affecting manual responses Inability to read text from 2 feet away (corrective lenses allowed)
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.
Citations:
PubMed Identifier
35230864
Citation
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.
Results Reference
derived

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

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