The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Minnesota
About this trial
Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
External electrical stimulation
DeviceElectrical stimulation
Ultrasound stimulation
DeviceUSS
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Acute electrical stimulation session versus no stimulation (sham).Experimental treatment 1 intervention
Group B: Acute ultrasound stimulation session versus no stimulation (sham).Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and post-stimulation assessment during the study visit, approximately 3 hours.Sponsors and contacts
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Source ClinicalTrials.gov