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Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.
This pilot early feasibility study in healthy participants is intended to establish quantitative physiological markers of cortical and autonomic modulation evoked by noninvasive electrical and/or ultrasound stimulation of the nervous system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute electrical stimulation session versus no stimulation (sham). | Experimental |
| |
| Acute ultrasound stimulation session versus no stimulation (sham). | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External electrical stimulation | Device | Electrical stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HD-EEG Power Spectrum Magnitude After Active Versus Sham Stimulation | Change from baseline in power spectrum magnitude will be calculated from high-density electroencephalography recordings in standard EEG frequency bands. The primary comparison will be the within-participant difference in change from baseline between active stimulation and sham stimulation conditions. | Baseline and post-stimulation assessment during the study visit, approximately 3 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosana Esteller, Principal Investigator, PhD | Contact | 612-624-1326 | tntlab-studies@umn.edu | |
| Sanjay Balaji, Study Coordinator, Ph.D. | Contact | tntlab-studies@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M Health Clinical Research Unit | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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This is a single-site exploratory study.
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| Ultrasound stimulation | Device | USS |
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| M Health Clinics and Surgery Center and satellite Neurology Clinic locations | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Translational Neurotechnology (TNT) Lab | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|