Stimulation Evaluation for Neuromodulation Sensory Effects

SENSE is a single-site, acute, sham-controlled study in healthy adult volunteers. The study will evaluate the tolerability and sensory effects of low-intensity Intersectional Short-Pulse (ISP) stimulation delivered using the study system. ISP stimulation uses brief electrical pulses distributed across multiple electrode contacts to produce a focused electrical field in the intended target region.

This study is not intended to treat any medical condition. Its purpose is to characterize how healthy adults experience study stimulation and to inform safe stimulation settings and study procedures for future clinical investigations.

Each participant will complete active ISP stimulation and sham stimulation conditions. During sham stimulation, the study procedures will be similar, but the therapeutic stimulation will not be delivered. Comparing active and sham conditions will help researchers understand whether reported sensations are related to stimulation rather than the study setting or participants' expectations.

The primary objective is to assess tolerability of active ISP stimulation. Tolerability assessments will include participant-reported sensations and discomfort, the intensity at which stimulation is first perceived, and the highest stimulation level that remains acceptable to the participant. Researchers will also document any stimulation-related symptoms or other adverse events.

Secondary objectives are to characterize the type, location, intensity, and consistency of sensations associated with ISP stimulation and to assess whether participants can distinguish active stimulation from sham stimulation. Researchers may evaluate whether responses remain stable across repeated stimulation sessions or stimulation settings.

Exploratory assessments may include recordings or measures of brain activity, muscle activity, and autonomic responses during stimulation, when applicable. These assessments may help characterize physiologic effects associated with active and sham stimulation and support selection of stimulation parameters for future studies.

Information from SENSE will support the development of safe, tolerable, and practical ISP stimulation procedures before evaluating the technology in people with epilepsy.

Inclusion criteria

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

Exclusion criteria

• 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,
• 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.
• Prior intracranial neurosurgical procedure or implanted neurostimulation device.
• Presence of an implanted electrical, neurostimulation, cardiac rhythm management, or other active implanted medical device.
• Significant scalp abnormalities that may interfere with electrode placement, including active skin disease, open wounds, infection, or severe dermatologic conditions involving the scalp.
• Current diagnosis of a major psychiatric disorder that, in the opinion of the investigator, may interfere with study participation or interpretation of study results.
• History of severe depression associated with suicidal ideation, suicidal behavior, suicide attempt, psychiatric hospitalization for suicidality.
• Current suicidal ideation or behavior, as determined by participant self-report.
• Current substance abuse and/or alcohol dependence that may impair the participant's ability to safely complete study procedures.
• Pregnant or breastfeeding.
• Participation in another investigational drug, biologic, or device study within 30 days prior to enrollment, unless approved by the investigator and sponsor.
• 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.
• 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.