Clinical trials

TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring. The study will assess the ability of sgEEG to detect seizures and characterize seizure timing, signal quality and stability, and lateralization compared with SEEG.

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.