Stimulation Evaluation for Neuromodulation Sensory Effects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAdraxe Corp.
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years.
Self-reported good general health, as assessed by study personnel.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Intersectional Short-Pulse (ISP) Stimulation
- Sham Stimulation
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov