Stimulation Evaluation for Neuromodulation Sensory Effects

Stimulation Evaluation for Neuromodulation Sensory Effects

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.

Inclusion Criteria:

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

Exclusion Criteria:

1. Non-English speaking
2. History of epilepsy, seizure disorder, unprovoked seizure, or status epilepticus.
3. History of febrile seizures beyond early childhood
4. Current use of medications known to substantially lower seizure threshold, including but not limited to certain antidepressants, antipsychotics, stimulants,
5. 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.
6. Prior intracranial neurosurgical procedure or implanted neurostimulation device.
7. Presence of an implanted electrical, neurostimulation, cardiac rhythm management, or other active implanted medical device.
8. Significant scalp abnormalities that may interfere with electrode placement, including active skin disease, open wounds, infection, or severe dermatologic conditions involving the scalp.
9. Current diagnosis of a major psychiatric disorder that, in the opinion of the investigator, may interfere with study participation or interpretation of study results.
10. History of severe depression associated with suicidal ideation, suicidal behavior, suicide attempt, psychiatric hospitalization for suicidality.
11. Current suicidal ideation or behavior, as determined by participant self-report.
12. Current substance abuse and/or alcohol dependence that may impair the participant's ability to safely complete study procedures.
13. Pregnant or breastfeeding.
14. Participation in another investigational drug, biologic, or device study within 30 days prior to enrollment, unless approved by the investigator and sponsor.
15. 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.
16. History of recurrent syncope, unexplained loss of consciousness, vasovagal episodes requiring medical intervention, or other conditions associated with increased risk of fainting during medical procedures or sensory stimulation, as determined by the investigator.