Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT07606573

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

External electrical stimulation

Ultrasound stimulation

Study Details

Brief summary:

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

Conditions

Healthy Adult Participants

Study ID

NCT07606573

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Acute electrical stimulation session versus no stimulation (sham).

experimental: Acute ultrasound stimulation session versus no stimulation (sham).

Interventions

External electrical stimulation

Electrical stimulation

Ultrasound stimulation

USS

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Rosana Esteller, Principal Investigator, PhD

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

Sanjay Balaji, Study Coordinator, Ph.D.

tntlab-studies@umn.edu

Locations

M Health Clinical Research Unit

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal investigator

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

M Health Clinics and Surgery Center and satellite Neurology Clinic locations

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal investigator

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

Translational Neurotechnology (TNT) Lab

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator, PhD

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

More Information

Sponsor

University of Minnesota

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-06-11.