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This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parameter Trials | Experimental | Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-intensity Focused Ultrasound | Device | LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG. |
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| Measure | Description | Time Frame |
|---|---|---|
| Waveforms | Changes in waveform peak will be observed per each variable application of LIFU | Outcome measured throughout study participation - an average of 4 weeks per participant. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to MRI, CT, or TMS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29968768 | Background | Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1. | |
| 33236981 | Background | Fomenko A, Chen KS, Nankoo JF, Saravanamuttu J, Wang Y, El-Baba M, Xia X, Seerala SS, Hynynen K, Lozano AM, Chen R. Systematic examination of low-intensity ultrasound parameters on human motor cortex excitability and behavior. Elife. 2020 Nov 25;9:e54497. doi: 10.7554/eLife.54497. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parameter Trials | Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG. Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parameter Trials | Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG. Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Waveforms | Changes in waveform peak will be observed per each variable application of LIFU | One participant data set had artifacts that could not be removed while leaving usable MEP data. | Posted | Mean | Standard Deviation | percentage of baseline MEP mV | Outcome measured throughout study participation - an average of 4 weeks per participant. |
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Beginning (prior to study tasks) and end of each study visit, visits occurring over an average of 4 weeks - participants completed report of symptoms questionnaire.
Collected a Report of Symptoms Questionnaire pre/post LIFU application at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parameter Trials | Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG. Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Florig | Fralin Biomedical Research Institute at VTC | 540-526-2261 | jnw@vtc.vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2024 | Sep 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2024 | Sep 12, 2024 | SAP_001.pdf |
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Multi-visit study, testing various LIFU parameters per session
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| 34487826 | Background | Xia X, Fomenko A, Nankoo JF, Zeng K, Wang Y, Zhang J, Lozano AM, Chen R. Time course of the effects of low-intensity transcranial ultrasound on the excitability of ipsilateral and contralateral human primary motor cortex. Neuroimage. 2021 Nov;243:118557. doi: 10.1016/j.neuroimage.2021.118557. Epub 2021 Sep 4. |
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| 23 |
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| 23 |
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