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NOT YET RECRUITING
NCT07777991
NA

Stimulation Evaluation for Neuromodulation Sensory Effects

Sponsor: Adraxe Corp.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-01

Completion Date

2027-09-01

Last Updated

2026-08-21

Healthy Volunteers

Yes

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.