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| Name | Class |
|---|---|
| Wellcome Leap Inc. | INDUSTRY |
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This study is testing a new treatment called IR-TMS (image-guided, robot navigated transcranial magnetic stimulation) to see if it can help people who drink too much alcohol to reduce the amount they drink. Participants will be placed into one of three groups, each receiving a slightly different version of this treatment. The study involves going through a few sessions of IR-TMS, having brain scans (MRI), providing blood and urine samples, and answering questions about their drinking and mental health. These activities are part of the study and aren't usually part of regular treatment for alcohol use.
IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain. The goal is to see if this treatment can help reduce the urge to drink. There are other options, like sticking with therapy or medication, which are less intense but have been used for a longer time.
Participants with AUD will undergo accelerated IR-TMS treatments and longitudinal fMRI scanning to determine treatment effects and durability. Participants will be recruited and randomized to 1 of 3 treatment target site regions: 1) Left dorsolateral prefrontal cortex; 2) Dorsomedial prefrontal cortex; or 3) Orbitofrontal Cortex. Each participant's target site region will be determined by personalized fMRI connectivity maps. Participants will receive up to 4 IR-TMS treatments per day for up to 10 days (total = 40 accelerated IR-TMS treatments) in an open-label clinical trial with an adaptive treatment design-if one target site region demonstrates superior treatment responses, the remaining participant sample will undergo IR-TMS treatments on that target site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left dorsolateral prefrontal cortex (L-DLPFC) IR-TMS | Active Comparator | Stimulation will be delivered to the L-DLPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks. |
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| Dorsomedial prefrontal cortex (DMPFC) IR-TMS | Active Comparator | Stimulation will be delivered to either the DMPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks. |
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| Orbitofrontal cortex (OFC) IR-TMS | Active Comparator | Stimulation will be delivered to either the OFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | TMS applies a strong (~2 Tesla), rapidly changing electro-magnetic field at the scalp to induce electrical current flow in underlying brain tissues |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Phosphatidylethanol (PEth) level | Determine if accelerated IR-TMS significantly changes alcohol consumption (as measured by phosphatidylethanol (PEth)) in participants with AUD. | Baseline, 1 month and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brain functional connectivity | Unified Structural Equation Modeling (SEM) analyses will be used for image analysis. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett C Ginsburg, PhD | Contact | 210-567-0871 | ginsburg@uthscsa.edu | |
| Tara Wright, PhD, MS | Contact | 210-450-3903 | wrightt3@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brett C Ginsburg, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences | Recruiting | San Antonio | Texas | 78229 | United States |
Final copies of all publications, abstracts, and presentations will be archived in the study's repository and made accessible to all study personnel, including the submitted version and any subsequent revisions.
Public policy will focus on ensuring that all dissemination of research findings from this study is conducted in an accurate, transparent and ethical manner.
At the time of study completion and publication in a peer review journal
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced 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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A 3-arm open label, adaptive randomized control trial
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