Not Yet RecruitingNot Applicable

Overnight TI in TLE

United States20 participantsStarted 2026-05-01

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 - 70 years * Diagnosis of focal drug-resistant temporal lobe epilepsy * Candidate for in-laboratory overnight monitoring with PSG and scalp EEG, with ability to comply with study procedures * Stable antiseizure medication regimen for at least 1 week prior to admission * Capacity to provide consent Exclusion Criteria: * Generalized epilepsy syndromes or primary generalized seizures * Recent status epilepticus, seizure clusters requiring emergency intervention, or other features indicating unacceptable risk for monitored participation * Uncontrolled psychiatric illness (e.g., acute psychosis, severe untreated depression with high suicide risk) * Implanted electronic or metallic devices incompatible with TI (e.g., certain pacemakers, cochlear implants) as per device manual * Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated * Dermatologic disease at electrode sites or known contact allergy to electrode materials * Pregnancy or breastfeeding * Concurrent enrollment in other interventional neuromodulation or pharmacological trials likely to confound EEG or sleep outcomes

What they're measuring

Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG

Timeframe: Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period).

Trial details

NCT IDNCT07434986

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

Contact for this trial

Matthew K Moye, BSc

919-668-9021 matthew.moye@duke.edu