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Recruiting NCT07606573

The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation

No phase Interventional Healthy Adult Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: External electrical stimulation, Ultrasound stimulation.
Who it may be relevant to
Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device External electrical stimulation
    Electrical stimulation
  • Device Ultrasound stimulation
    USS

Primary outcome measures

  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 3 centers
  • M Health Clinical Research Unit — Minneapolis
  • M Health Clinics and Surgery Center and satellite Neurology Clinic locations — Minneapolis
  • Translational Neurotechnology (TNT) Lab — Minneapolis

Identifiers

NCT: NCT07606573 · STUDY00027691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗