Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

Rebecca Price

Status: Enrolling

Conditions: Obsessive-Compulsive Disorder; Compulsive Behavior

Treatments: Behavioral: Habit Override Practice; Device: Sham Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation; Behavioral: Sham Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04580043

STUDY19090219 (Part 2)

R01MH124707 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

cTBS + Habit Override Training

Experimental group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation

Behavioral: Habit Override Practice

Sham TBS + Habit Override Training

Active Comparator group

Description:

Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Behavioral: Habit Override Practice

cTBS + Sham Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Sham Training

Device: Transcranial Magnetic Stimulation

Sham TBS + Sham Training

Sham Comparator group

Description:

Sham Transcranial Magnetic Stimulation, paired with Sham Training.

Treatment:

Behavioral: Sham Training

Device: Sham Transcranial Magnetic Stimulation