Overnight TI in TLE

The goal of this clinical trial is to gauge whether overnight, non-invasive temporal interference (TI) stimulation aimed at the hippocampus can reduce abnormal brain activity linked to seizures and improve sleep in adults with drug-resistant temporal lobe epilepsy. The main questions are: Does overnight TI stimulation lower seizure-related EEG activity during sleep? Does overnight TI stimulation improve sleep quality and sleep patterns measured overnight in the lab? Researchers will compare each participant's nights without stimulation to nights with active stimulation, and will also look at a night after stimulation ends to see whether any changes last. Participants will: Stay in-lab for six days for overnight sleep and EEG monitoring Have one night of monitoring without stimulation Receive TI stimulation during sleep for several nights Have another night of monitoring without stimulation after the stimulation nights Complete brief questionnaires and thinking/memory tasks before and after the stimulation nights Be checked for side effects and comfort during the study and at follow-up

NCT Number	NCT07434986
Lead Sponsor	Duke University Collaborators: St. Anne's University Hospital Brno, Czech Republic
Conditions	Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep
Enrollment	20 participants
Start Date	2026-06-01
Primary Completion	2026-10-30 (estimated)
Study Completion	2026-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-12