The UMPIRE study: A first-in-human multicenter trial of bilateral subscalp monitoring for epileptic seizure detection.

ABSTRACT:

Objective

Patient self-report is known to be an inaccurate reflection of true seizure frequency in persons with epilepsy. The current study aimed to assess the safety and performance of the Minder system, a bilateral subscalp electroencephalographic (EEG) acquisition system for continuous long-term EEG recording.

Methods

This prospective, multicenter first-in-human study enrolled adult patients with focal or generalized epilepsy and at least two seizures per month. The primary outcome was adverse events (AEs) in the first 6 months of implantation. Secondary analyses determined whether normal neurophysiological signals, interictal discharges, and seizures seen on scalp video-EEG monitoring were identifiable on subscalp recordings, and signals were rated for clarity on subscal

SUBMITTER: Halliday AJ 

PROVIDER: S-EPMC12455381 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature