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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH124707 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTBS + Habit Override Training | Experimental | Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training. |
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| Sham TBS + Habit Override Training | Active Comparator | Sham Transcranial Magnetic Stimulation, paired with Habit Override Training. |
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| cTBS + Sham Training | Active Comparator | Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training. |
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| Sham TBS + Sham Training | Sham Comparator | Sham Transcranial Magnetic Stimulation, paired with Sham Training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habit Override Practice | Behavioral | Computerized "brain training" to provide practice in overriding avoidance habits. |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain activation in target region | Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI) | 10-60min post-intervention |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Goal-directed cognition | Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance) | 90min-1 week |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |
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Inclusion Criteria:
Participants will:
Exclusion Criteria:
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.
Medical contraindications for Transcranial Magnetic Stimulation (TMS):
Acute suicidality or other psychiatric crises requiring treatment escalation
Changes made to treatment regimen within 4 weeks of baseline assessment
Reading level <6th grade as per participant self-report
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)
Presence of movement disorder or tics affecting manual responses
Inability to read text from 2 feet away (corrective lenses allowed)
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca B Price, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 6, 2025 | Feb 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Transcranial Magnetic Stimulation | Device | Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern. |
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| Sham Training | Behavioral | Computer-based task practice in a non-active/inert task. |
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| Sham Transcranial Magnetic Stimulation | Device | Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern. |
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Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
| 1 week |
| WHO Disability Assessment Scale 2.0 | Self-report measure of general functioning and disability (0-100; higher score=worse outcome) | 1 week |
| Obsessive Compulsive Inventory-Revised (OCI-R) | Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome) | 1 week |
| 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 |
| 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 |
| 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 |
| Brain activation in target region | Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI) | 1 week |