Sham-controlledSENSENCT07777991
Stimulation Evaluation for Neuromodulation Sensory Effects
A study testing Intersectional Short-Pulse (ISP) Stimulation in people with Sham-controlled and Healthy Adult Participants, run by Adraxe Corp..
Trial summary
The goal of this clinical trial is to learn how healthy adults experience low-level electrical stimulation delivered through the study device. This study is not intended to treat a medical condition. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sham-controlled, Healthy Adult Participants, Electric Stimulation
- What is being tested?
- Intersectional Short-Pulse (ISP) Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Self-reported good general health, as assessed by study personnel.
Who cannot join
- Non-English speaking
- History of epilepsy, seizure disorder, unprovoked seizure, or status epilepticus.
- History of febrile seizures beyond early childhood
- Current use of medications known to substantially lower seizure threshold, including but not limited to certain antidepressants, antipsychotics, stimulants,
- History of significant neurological disease, including stroke, traumatic brain injury with loss of consciousness, brain tumor, neurodegenerative disease, multiple sclerosis, or other clinically significant neurological disorders.
- Prior intracranial neurosurgical procedure or implanted neurostimulation device.
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- Presence of an implanted electrical, neurostimulation, cardiac rhythm management, or other active implanted medical device.
- Significant scalp abnormalities that may interfere with electrode placement, including active skin disease, open wounds, infection, or severe dermatologic conditions involving the scalp.
- Current diagnosis of a major psychiatric disorder that, in the opinion of the investigator, may interfere with study participation or interpretation of study results.
- History of severe depression associated with suicidal ideation, suicidal behavior, suicide attempt, psychiatric hospitalization for suicidality.
- Current suicidal ideation or behavior, as determined by participant self-report.
- Current substance abuse and/or alcohol dependence that may impair the participant's ability to safely complete study procedures.
- Pregnant or breastfeeding.
- Participation in another investigational drug, biologic, or device study within 30 days prior to enrollment, unless approved by the investigator and sponsor.
- History of migraine with aura, photosensitive migraine, recurrent phosphenes, visually induced neurological symptoms, or other conditions associated with heightened susceptibility to visual sensory phenomena, as determined by the investigator.
- History of recurrent syncope, unexplained loss of consciousness, vasovagal episodes requiring medical intervention, or other conditions associated with increased risk of fainting during medical procedures or sensory stimulation, as determined by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn how healthy adults experience low-level electrical stimulation delivered through the study device. This study is not intended to treat a medical condition.
The main questions it aims to answer are:
Read more
Is the study stimulation comfortable and well tolerated? What sensations do participants notice during stimulation? Can participants tell the difference between active stimulation and sham stimulation?
Researchers will compare active stimulation with sham stimulation. Sham stimulation uses the same study procedures but does not deliver the study stimulation. This comparison will help researchers understand whether sensations are caused by stimulation rather than the study setting or expectations.
Participants will:
Receive brief sessions of active and sham stimulation using the study device. Report sensations, discomfort, or other effects during and after each session. Complete questionnaires or other assessments about their experience with stimulation.
The information from this study will help researchers select stimulation settings and procedures for future studies.
Read the detailed description
SENSE is a single-site, acute, sham-controlled study in healthy adult volunteers. The study will evaluate the tolerability and sensory effects of low-intensity Intersectional Short-Pulse (ISP) stimulation delivered using the study system. ISP stimulation uses brief electrical pulses distributed across multiple electrode contacts to produce a focused electrical field in the intended target region.
This study is not intended to treat any medical condition. Its purpose is to characterize how healthy adults experience study stimulation and to inform safe stimulation settings and study procedures for future clinical investigations.
Each participant will complete active ISP stimulation and sham stimulation conditions. During sham stimulation, the study procedures will be similar, but the therapeutic stimulation will not be delivered. Comparing active and sham conditions will help researchers understand whether reported sensations are related to stimulation rather than the study setting or participants' expectations.
The primary objective is to assess tolerability of active ISP stimulation. Tolerability assessments will include participant-reported sensations and discomfort, the intensity at which stimulation is first perceived, and the highest stimulation level that remains acceptable to the participant. Researchers will also document any stimulation-related symptoms or other adverse events.
Secondary objectives are to characterize the type, location, intensity, and consistency of sensations associated with ISP stimulation and to assess whether participants can distinguish active stimulation from sham stimulation. Researchers may evaluate whether responses remain stable across repeated stimulation sessions or stimulation settings.
Exploratory assessments may include recordings or measures of brain activity, muscle activity, and autonomic responses during stimulation, when applicable. These assessments may help characterize physiologic effects associated with active and sham stimulation and support selection of stimulation parameters for future studies.
Information from SENSE will support the development of safe, tolerable, and practical ISP stimulation procedures before evaluating the technology in people with epilepsy.
- Being tested
- Intersectional Short-Pulse (ISP) Stimulation, Sham Stimulation
- Keywords
- Healthy volunteers, Electrical stimulation, Intersectional Short-Pulse (ISP) stimulation, Neuromodulation, Sensory effects, Sham-controlled, Noninvasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intersectional Short-Pulse (ISP) StimulationDevice
Active Intersectional Short-Pulse (ISP) stimulation is low-level electrical stimulation delivered through the study device during brief study sessions. The study team will apply stimulation using pre-specified settings and monitor participant comfort. Participants will report any sensations or discomfort during and after stimulation.
Sham StimulationDevice
Sham stimulation uses the same study device, electrode placement, and study procedures as active ISP stimulation, but does not deliver the study stimulation. It is included to help compare participant-reported sensations during active and sham sessions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | Each subject will receive both active and sham stimulation Receives: Device: Intersectional Short-Pulse (ISP) Stimulation; Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Active and Sham Stimulation Sessions Without Intolerable Discomfort or Session Discontinuation
Participant ability to distinguish active stimulation from sham stimulation will be assessed by the participant's post-session identification of the stimulation condition. The proportion of correct condition identifications will be summarized and evaluated relative to chance performance.
Measured: From enrollment to the end of the, approximately 2 hour, stimulation session.
Healthy adult volunteers- receive low amplitude sham and active ISP stimulation
Measured: From enrollment to the end of the single day assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sham-controlledStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adraxe Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosana Esteller, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777991
- Sponsor's protocol ID
- ADX-CP-001
- Acronym
- SENSE
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation Evaluation for Neuromodulation Sensory Effects
- ClinicalTrials.gov ID
- NCT07777991
- Acronym / sponsor ID
- SENSE / ADX-CP-001
- Keywords
- Healthy volunteers, Electrical stimulation, Intersectional Short-Pulse (ISP) stimulation, Neuromodulation, Sensory effects, Sham-controlled, Noninvasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Adraxe Corp.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Aug 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.
The goal of this clinical trial is to learn how healthy adults experience low-level electrical stimulation delivered through the study device. This study is not intended to treat a medical condition.
The main questions it aims to answer are:
Is the study stimulation comfortable and well tolerated? What sensations do participants notice during stimulation? Can participants tell the difference between active stimulation and sham stimulation?
Researchers will compare active stimulation with sham stimulation. Sham stimulation uses the same study procedures but does not deliver the study stimulation. This comparison will help researchers understand whether sensations are caused by stimulation rather than the study setting or expectations.
Participants will:
Receive brief sessions of active and sham stimulation using the study device. Report sensations, discomfort, or other effects during and after each session. Complete questionnaires or other assessments about their experience with stimulation.
The information from this study will help researchers select stimulation settings and procedures for future studies.
Detailed description
SENSE is a single-site, acute, sham-controlled study in healthy adult volunteers. The study will evaluate the tolerability and sensory effects of low-intensity Intersectional Short-Pulse (ISP) stimulation delivered using the study system. ISP stimulation uses brief electrical pulses distributed across multiple electrode contacts to produce a focused electrical field in the intended target region.
This study is not intended to treat any medical condition. Its purpose is to characterize how healthy adults experience study stimulation and to inform safe stimulation settings and study procedures for future clinical investigations.
Each participant will complete active ISP stimulation and sham stimulation conditions. During sham stimulation, the study procedures will be similar, but the therapeutic stimulation will not be delivered. Comparing active and sham conditions will help researchers understand whether reported sensations are related to stimulation rather than the study setting or participants' expectations.
The primary objective is to assess tolerability of active ISP stimulation. Tolerability assessments will include participant-reported sensations and discomfort, the intensity at which stimulation is first perceived, and the highest stimulation level that remains acceptable to the participant. Researchers will also document any stimulation-related symptoms or other adverse events.
Secondary objectives are to characterize the type, location, intensity, and consistency of sensations associated with ISP stimulation and to assess whether participants can distinguish active stimulation from sham stimulation. Researchers may evaluate whether responses remain stable across repeated stimulation sessions or stimulation settings.
Exploratory assessments may include recordings or measures of brain activity, muscle activity, and autonomic responses during stimulation, when applicable. These assessments may help characterize physiologic effects associated with active and sham stimulation and support selection of stimulation parameters for future studies.
Information from SENSE will support the development of safe, tolerable, and practical ISP stimulation procedures before evaluating the technology in people with epilepsy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Device: Intersectional Short-Pulse (ISP) Stimulation, Device: Sham StimulationEach subject will receive both active and sham stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years.
- Self-reported good general health, as assessed by study personnel.
Key exclusion criteria (16 listed)
- Non-English speaking
- History of epilepsy, seizure disorder, unprovoked seizure, or status epilepticus.
- History of febrile seizures beyond early childhood
- Current use of medications known to substantially lower seizure threshold, including but not limited to certain antidepressants, antipsychotics, stimulants,
- History of significant neurological disease, including stroke, traumatic brain injury with loss of consciousness, brain tumor, neurodegenerative disease, multiple sclerosis, or other clinically significant neurological disorders.
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 |
|---|---|---|
| Intersectional Short-Pulse (ISP) StimulationActive Intersectional Short-Pulse (ISP) stimulation is low-level electrical stimulation delivered through the study device during brief study sessions. The study team will apply stimulation using pre-specified settings and monitor participant comfort. Participants will report any sensations or discomfort during and after stimulation. | Device | Healthy Volunteer |
| Sham StimulationSham stimulation uses the same study device, electrode placement, and study procedures as active ISP stimulation, but does not deliver the study stimulation. It is included to help compare participant-reported sensations during active and sham sessions. | Device | Healthy Volunteer |
Primary outcome
Number of Participants Who Complete Active and Sham Stimulation Sessions Without Intolerable Discomfort or Session Discontinuation
Time frame: From enrollment to the end of the, approximately 2 hour, stimulation session.
Participant ability to distinguish active stimulation from sham stimulation will be assessed by the participant's post-session identification of the stimulation condition. The proportion of correct condition identifications will be summarized and evaluated relative to chance performance.
Healthy adult volunteers- receive low amplitude sham and active ISP stimulation
Time frame: From enrollment to the end of the single day assessment
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 21 Aug 2026.
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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.
Rosana Esteller, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Intersectional Short-Pulse (ISP) Stimulation in people with Sham-controlled and Healthy Adult Participants, run by Adraxe Corp..
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 16 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Marina Research Manager (763-807-1858, epilepsy@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Complete Active and Sham Stimulation Sessions Without Intolerable Discomfort or Session Discontinuation (time frame: From enrollment to the end of the, approximately 2 hour, stimulation session.). The study lists 2 primary outcomes in all. 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 21 Aug 2026.