All participants are to receive a stimulator connected to depth or cortical electrodes placed at no more than two identified seizure foci. One month after implantation, participants will be randomized one to one to active or sham stimulation, with 48 in each group. Participants and outcome assessors are blinded, and the stated objective is to generate safety and effectiveness evidence for product registration.
The initial registry record listed the study as not yet recruiting, while later hospital announcements and Neuracle’s prospectus confirm that the multicenter program moved forward. Public records do not show that overall enrollment passed 50% or support a forecast of full enrollment within the year. The device combines intracranial EEG recording, abnormal-activity detection and stimulation and should not be described as a monitoring electrode alone.