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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Intersectional Short-Pulse (ISP) Stimulation
DeviceActive 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 Stimulation
DeviceSham 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Healthy VolunteerExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of the, approximately 2 hour, stimulation session.2
Healthy adult volunteers- receive low amplitude sham and active ISP stimulation
Time frame
From enrollment to the end of the single day assessmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: