Healthy Adult ParticipantsNCT07606573
The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation
A study testing External electrical stimulation and Ultrasound stimulation in people with Healthy Adult Participants, run by University of Minnesota at 3 sites in United States.
Trial summary
Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- External electrical stimulation and Ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sanjay Balaji, Study Coordinator, Ph.D. contact
United States3 sites, 3 recruiting
- Recruiting
M Health Clinical Research Unit
Minneapolis, Minnesota, 55455
Principal investigator, 612-624-1326, tntlab-studies@umn.edu
- Recruiting
M Health Clinics and Surgery Center and satellite Neurology Clinic locations
Minneapolis, Minnesota, 55455
Principal investigator, 612-624-1326, tntlab-studies@umn.edu
- Recruiting
Translational Neurotechnology (TNT) Lab
Minneapolis, Minnesota, 55455
Principal Investigator, PhD, 612-624-1326, tntlab-studies@umn.edu
About this study
Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- External electrical stimulation, Ultrasound stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External electrical stimulationDevice
Electrical stimulation
Ultrasound stimulationDevice
USS
| Study group | Role | What they receive |
|---|---|---|
| Acute electrical stimulation session versus no stimulation (sham). | Experimental | Not described Receives: Device: External electrical stimulation |
| Acute ultrasound stimulation session versus no stimulation (sham). | Experimental | Not described Receives: Device: Ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-stimulation assessment during the study visit, approximately 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start8 Jun 2026
- Primary completionJul 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single-site exploratory study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606573
- Sponsor's protocol ID
- STUDY00027691
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SEAS Study: Sensory Engagement and Activation During Noninvasive Stimulation
- ClinicalTrials.gov ID
- NCT07606573
- Acronym / sponsor ID
- STUDY00027691
- Conditions
- Healthy Adult Participants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-site exploratory study.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External electrical stimulationElectrical stimulation | Device | Acute electrical stimulation session versus no stimulation (sham). |
| Ultrasound stimulationUSS | Device | Acute ultrasound stimulation session versus no stimulation (sham). |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjay Balaji, Study Coordinator, Ph.D. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External electrical stimulation and Ultrasound stimulation in people with Healthy Adult Participants, run by University of Minnesota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosana Esteller, Principal Investigator, PhD (612-624-1326, tntlab-studies@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.