Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580043
• Other study ID #: STUDY19090219 (Part 2)
• Secondary ID: R01MH124707
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: January 2, 2027

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Rebecca Price, PhD
• Phone: 4126486445
• Email: canlab[@]pitt.edu
• 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 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: Recruiting
• Enrollment: 200
• Est. completion date: January 2, 2027
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Habit Override Practice
Computerized "brain training" to provide practice in overriding avoidance habits.

Device:
• Transcranial Magnetic Stimulation
Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Behavioral:
• Sham Training
Computer-based task practice in a non-active/inert task.

Device:
• Sham Transcranial Magnetic Stimulation
Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rebecca Price	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activation in target region	Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)	10-60min post-intervention
Primary	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)	60min post-intervention
Primary	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)	60min post-intervention
Primary	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)	60min post-intervention
Secondary	Goal-directed cognition	Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)	90min-1 week
Secondary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)	1 week
Secondary	WHO Disability Assessment Scale 2.0	Self-report measure of general functioning and disability (0-100; higher score=worse outcome)	1 week
Secondary	Obsessive Compulsive Inventory-Revised (OCI-R)	Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)	1 week
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 (0-100 scale)	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 (% of total time allotted)	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 (0-100 scale)	1 week
Secondary	Brain activation in target region	Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)	1 week