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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265015
• Other study ID #: STUDY19090219 (Part 1)
• Secondary ID: R21MH112770
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: August 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional Magnetic Resonance Imaging (fMRI)	Brain activation in target region	10-60min
Secondary	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	90min-1 week
Secondary	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	90min-1 week
Secondary	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	90min-1 week
Secondary	Two-step task	Neuropsychological test of flexible goal-directed cognition	90min-1 week
Secondary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Clinician-administered measurement of obsessions and compulsions	1 week
Secondary	WHO Disability Assessment Scale 2.0	Self-report measure of general functioning and disability	1 week
Secondary	Obsessive Compulsive Inventory-Revised (OCI-R)	Self-report measure of obsessions and compulsions	1 week
Secondary	Habit override task	Percentage of correct responses to each stimulus (0-100%; higher score=better performance)	1 week