The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation

Purpose

Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.

Condition

  • Healthy Adult Participants

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
This is a single-site exploratory study.
Primary Purpose
Basic Science
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acute electrical stimulation session versus no stimulation (sham).
  • Device: External electrical stimulation
    Electrical stimulation
Experimental
Acute ultrasound stimulation session versus no stimulation (sham).
  • Device: Ultrasound stimulation
    USS

Recruiting Locations

M Health Clinical Research Unit
Minneapolis, Minnesota 55455
Contact:
Principal investigator
612-624-1326
tntlab-studies@umn.edu

M Health Clinics and Surgery Center and satellite Neurology Clinic locations
Minneapolis, Minnesota 55455
Contact:
Principal investigator
612-624-1326
tntlab-studies@umn.edu

Translational Neurotechnology (TNT) Lab
Minneapolis, Minnesota 55455
Contact:
Principal Investigator, PhD
612-624-1326
tntlab-studies@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Rosana Esteller, Principal Investigator, PhD
612-624-1326
tntlab-studies@umn.edu

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.