Healthy Adult Participants
Conditions
Brief summary
Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.
Detailed description
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.
Interventions
Electrical stimulation
DEVICEUltrasound stimulation
USS
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
This is a single-site exploratory study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to provide written informed consent in English. * Willing and able to complete study procedures (e.g., \~1-hour sessions with non-invasive recordings, \~3-hour visit).
Exclusion criteria
* History of neurological disorders (e.g., epilepsy, migraines) or psychiatric conditions requiring medication. * Active implanted medical devices (e.g., pacemakers, cochlear implants) or metal in the neck/forearm that could interfere with stimulation or recordings. * Skin conditions or open wounds at stimulation sites (cervical neck, forearm). * Women who are pregnant or breastfeeding. * Current use of medications affecting autonomic or cortical function (e.g., beta-blockers, sedatives). * Inability to sit still for recordings or understand instructions (e.g., due to severe vision/hearing impairment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HD-EEG Power Spectrum Magnitude After Active Versus Sham Stimulation | Baseline and post-stimulation assessment during the study visit, approximately 3 hours. | 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. |
Countries
United States
Contacts
CONTACTRosana Esteller, Principal Investigator, PhD
CONTACTSanjay Balaji, Study Coordinator, Ph.D.
Outcome results
None listed