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Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

Primary Purpose

Compulsive Behavior, Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit Override Practice
Transcranial Magnetic Stimulation
Sham Training
Sham Transcranial Magnetic Stimulation
Sponsored by
Rebecca Price
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Compulsive Behavior

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Western Psychiatric Institute and ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Arm Label

cTBS + Habit Override Training

Sham TBS + Habit Override Training

cTBS + Sham Training

Sham TBS + Sham Training

Arm Description

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.

Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.

Sham Transcranial Magnetic Stimulation, paired with Sham Training.

Outcomes

Primary Outcome Measures

Brain activation in target region
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
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
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
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

Goal-directed cognition
Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
WHO Disability Assessment Scale 2.0
Self-report measure of general functioning and disability (0-100; higher score=worse outcome)
Obsessive Compulsive Inventory-Revised (OCI-R)
Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
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 (0-100 scale)
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 (% of total time allotted)
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 (0-100 scale)
Brain activation in target region
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)

Full Information

First Posted
October 1, 2020
Last Updated
July 3, 2023
Sponsor
Rebecca Price
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04580043
Brief Title
Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors
Official Title
Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
January 2, 2026 (Anticipated)
Study Completion Date
January 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca Price
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
Yes
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 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
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cTBS + Habit Override Training
Arm Type
Experimental
Arm Description
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
Arm Title
Sham TBS + Habit Override Training
Arm Type
Active Comparator
Arm Description
Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
Arm Title
cTBS + Sham Training
Arm Type
Active Comparator
Arm Description
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
Arm Title
Sham TBS + Sham Training
Arm Type
Sham Comparator
Arm Description
Sham Transcranial Magnetic Stimulation, paired with Sham Training.
Intervention Type
Behavioral
Intervention Name(s)
Habit Override Practice
Intervention Description
Computerized "brain training" to provide practice in overriding avoidance habits.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
cTBS
Intervention Description
Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Intervention Type
Behavioral
Intervention Name(s)
Sham Training
Intervention Description
Computer-based task practice in a non-active/inert task.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation
Other Intervention Name(s)
Sham cTBS
Intervention Description
Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Primary Outcome Measure Information:
Title
Brain activation in target region
Description
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Time Frame
10-60min post-intervention
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 (0-100 scale)
Time Frame
60min post-intervention
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 (% of total time allotted)
Time Frame
60min post-intervention
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 (0-100 scale)
Time Frame
60min post-intervention
Secondary Outcome Measure Information:
Title
Goal-directed cognition
Description
Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
Time Frame
90min-1 week
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
Time Frame
1 week
Title
WHO Disability Assessment Scale 2.0
Description
Self-report measure of general functioning and disability (0-100; higher score=worse outcome)
Time Frame
1 week
Title
Obsessive Compulsive Inventory-Revised (OCI-R)
Description
Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
Time Frame
1 week
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 (0-100 scale)
Time Frame
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 (% of total time allotted)
Time Frame
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 (0-100 scale)
Time Frame
1 week
Title
Brain activation in target region
Description
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will: Be between the ages of 18 and 60 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Price, PhD
Phone
4126486445
Email
canlab@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca B Price, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Price, PhD
Phone
412-648-6445
Email
canlab@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

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