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NCT Number: NCT07606573

The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M Health Clinical Research Unit, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

External electrical stimulation

Device

Electrical stimulation

Ultrasound Stimulation

Device

USS

Primary outcomes

  1. Change From Baseline in HD-EEG Power Spectrum Magnitude After Active Versus Sham Stimulation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosana Esteller, Principal Investigator, PhD

CONTACT

[email protected]

612-624-1326

Sanjay Balaji, Study Coordinator, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 26, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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