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Stimulation Evaluation for Neuromodulation Sensory Effects

NCT07777991 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-21

No results posted yet for this study

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

Interventions

DEVICE

Intersectional Short-Pulse (ISP) Stimulation

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.

DEVICE

Sham Stimulation

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.

Sponsors & Collaborators

  • Adraxe Corp.

    lead INDUSTRY

Principal Investigators

  • Rosana Esteller, PhD · University of Minnesota

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777991 on ClinicalTrials.gov