Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

Not Applicable

Recruiting

• Conditions: Compulsive Behavior; Obsessive-Compulsive Disorder
• Interventions: Behavioral: Habit Override Practice; Behavioral: Sham Training; Device: Sham Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation

• Registration Number: NCT04580043
• Lead Sponsor: Rebecca Price

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 available

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2020-12-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-01-02
• Study Completion: 2027-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)

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 as per participant self-report

6. Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TBS + Sham Training	Sham Transcranial Magnetic Stimulation	Sham Transcranial Magnetic Stimulation, paired with Sham Training.
cTBS + Habit Override Training	Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
Sham TBS + Habit Override Training	Habit Override Practice	Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
cTBS + Habit Override Training	Habit Override Practice	Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
Sham TBS + Habit Override Training	Sham Transcranial Magnetic Stimulation	Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
cTBS + Sham Training	Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
Sham TBS + Sham Training	Sham Training	Sham Transcranial Magnetic Stimulation, paired with Sham Training.
cTBS + Sham Training	Sham Training	Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.

Primary Outcome Measures

Name	Time	Method
Duration of compulsive behaviors in response to laboratory triggers	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	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)
Brain activation in target region	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	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)

Secondary Outcome Measures

Name	Time	Method
Goal-directed cognition	90min-1 week	Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
Obsessive Compulsive Inventory-Revised (OCI-R)	1 week	Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
Intensity of urges to perform compulsive behaviors in response to laboratory triggers	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	1 week	Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	1 week	Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
Effort to resist compulsive behaviors in response to laboratory triggers	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)
WHO Disability Assessment Scale 2.0	1 week	Self-report measure of general functioning and disability (0-100; higher score=worse outcome)
Duration of compulsive behaviors in response to laboratory triggers	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)

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States