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| Name | Class |
|---|---|
| BRAINBox Solutions Inc | INDUSTRY |
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Through the BrainBox Initiative, investigators propose to study the effects of motor tFUS on Motor Evoked Potentials (MEPs) and GABA and Glutamate Concentrations in the Brain.
tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus. tFUS has recently been used to probe deep brain structures in unresponsive wakefulness, pain, anxiety, and other neuropsychiatric conditions. However, tFUS is restricted mainly by use in the MR scanner environment, thus limiting session numbers by scan cost and participant comfort. Furthermore, with few human studies to date, the parameter space and mechanisms of action warrant further elucidation. Using novel focused ultrasound methods, investigators can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, investigators propose to study the effects of motor tFUS on motor-evoked potentials (MEPs) and GABA concentration. The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excitatory tFUS parameters effect on Motor Evoked Potentials | Experimental | All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle. |
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| Inhibitory tFUS parameters effect of Motor Evoked Potentials | Experimental | All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 5% duty cycle |
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| Sham tFUS parameters effect of Motor Evoked Potentials | Sham Comparator | All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will utilize an air-filled spacer to block stimulation from reaching the brain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Ultrasound Stimulation | Device | This aim will test whether motor tFUS parameters thought to be excitatory (50% duty cycle) vs. inhibitory (5% duty cycle) elicit their predicted effects on MEPs before and after each of three stimulation blocks, using 50 MEPs at each time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Evoked Potential Amplitude | How has the focused ultrasound stimulation affected MEP amplitude | Immediate Post-Stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa M McTeague, Ph.D. | Contact | 8437928274 | mcteague@musc.edu | |
| Kevin A Caulfield | Contact | caulfiel@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | 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 | Nov 2, 2022 | Feb 24, 2026 | ICF_001.pdf |
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Within-subject, each participant will receive one excitatory course of stimulation and one inhibitory course of stimulation of the motor cortex.
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Device stimulation will be blinded by the outcomes assessor to maintain the blinding of the participants and care provider
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