Clinical trial NCT04580043: 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
Overall status: RECRUITING
Phase: NA
Conditions: Compulsive Behavior
Obsessive-Compulsive Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Brain activation in target region
timeFrame: 10-60min post-intervention
measure: Effort to resist compulsive behaviors in response to laboratory triggers
timeFrame: 60min post-intervention
measure: Duration of compulsive behaviors in response to laboratory triggers
timeFrame: 60min post-intervention
measure: Intensity of urges to perform compulsive behaviors in response to laboratory triggers
timeFrame: 60min post-intervention
Secondary outcomes:
measure: Goal-directed cognition
timeFrame: 90min-1 week
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 1 week
measure: WHO Disability Assessment Scale 2.0
timeFrame: 1 week
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
timeFrame: 1 week
measure: Effort to resist compulsive behaviors in response to laboratory triggers
timeFrame: 1 week
measure: Duration of compulsive behaviors in response to laboratory triggers
timeFrame: 1 week
measure: Intensity of urges to perform compulsive behaviors in response to laboratory triggers
timeFrame: 1 week
measure: Brain activation in target region
timeFrame: 1 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rebecca B Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: