Stimulation Evaluation for Neuromodulation Sensory Effects

NCT07777991 | Not Yet Recruiting

• 1 other identifier: ADX-CP-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sham-controlled; Healthy Adult Participants; Electric Stimulation

Keywords

Healthy volunteers; Electrical stimulation; Intersectional Short-Pulse (ISP) stimulation; Neuromodulation; Sensory effects; Sham-controlled; Noninvasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of the, approximately 2 hour, stimulation session.

• Healthy adult volunteers- receive low amplitude sham and active ISP stimulation

  From enrollment to the end of the single day assessment

Study Arms (1)

Healthy Volunteer

EXPERIMENTAL

Each subject will receive both active and sham stimulation

Device: Intersectional Short-Pulse (ISP) Stimulation; Device: Sham Stimulation

Interventions

Intersectional Short-Pulse (ISP) Stimulation DEVICE

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.

Healthy Volunteer

Sham Stimulation DEVICE

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.

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Self-reported good general health, as assessed by study personnel.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Adraxe Corp.: lead

Study Officials

• Rosana Esteller, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Research Manager

CONTACT

763-807-1858; epilepsy@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08