The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation

NCT07606573 | Recruiting FDA Device

• 1 other identifier: STUDY00027691
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Healthy Adult Participants

Outcome Measures

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.

  Baseline and post-stimulation assessment during the study visit, approximately 3 hours.

Study Arms (2)

Acute electrical stimulation session versus no stimulation (sham).

EXPERIMENTAL

Device: External electrical stimulation

Acute ultrasound stimulation session versus no stimulation (sham).

EXPERIMENTAL

Device: Ultrasound stimulation

Interventions

External electrical stimulation DEVICE

Electrical stimulation

Acute electrical stimulation session versus no stimulation (sham).

Ultrasound stimulation DEVICE

USS

Acute ultrasound stimulation session versus no stimulation (sham).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (3)

M Health Clinical Research Unit

Minneapolis, Minnesota, 55455, United States

RECRUITING

M Health Clinics and Surgery Center and satellite Neurology Clinic locations

Minneapolis, Minnesota, 55455, United States

RECRUITING

Translational Neurotechnology (TNT) Lab

Minneapolis, Minnesota, 55455, United States

RECRUITING

Central Study Contacts

Rosana Esteller, Principal Investigator, PhD

CONTACT

612-624-1326; tntlab-studies@umn.edu

Sanjay Balaji, Study Coordinator, Ph.D.

CONTACT

tntlab-studies@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-site exploratory study.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 26, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)