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

NCT ID: NCT03265015

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Compulsive Behavior Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cTBS

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.

Group Type EXPERIMENTAL

Habit Override Practice

Intervention Type BEHAVIORAL

Computerized "brain training" to provide practice in overriding avoidance habits.

Transcranial Magnetic Stimulation

Intervention Type OTHER

Non-invasive method for temporary, focal stimulation of brain areas.

iTBS

Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.

Group Type ACTIVE_COMPARATOR

Habit Override Practice

Intervention Type BEHAVIORAL

Computerized "brain training" to provide practice in overriding avoidance habits.

Transcranial Magnetic Stimulation

Intervention Type OTHER

Non-invasive method for temporary, focal stimulation of brain areas.

Interventions

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Habit Override Practice

Computerized "brain training" to provide practice in overriding avoidance habits.

Intervention Type BEHAVIORAL

Transcranial Magnetic Stimulation

Non-invasive method for temporary, focal stimulation of brain areas.

Intervention Type OTHER

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Price

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Brown VM, Gillan CM, Renard M, Kaskie R, Degutis M, Wears A, Siegle GJ, Ferrarelli F, Ahmari SE, Price RB. A double-blind study assessing the impact of orbitofrontal theta burst stimulation on goal-directed behavior. J Psychopathol Clin Sci. 2022 Apr;131(3):287-300. doi: 10.1037/abn0000733. Epub 2022 Feb 7.

Reference Type DERIVED
PMID: 35230864 (View on PubMed)

Other Identifiers

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R21MH112770

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19090219 (Part 1)

Identifier Type: -

Identifier Source: org_study_id

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