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Overnight TI in TLE

Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy

Who can join

Ages 18 to 70 · All sexes

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

About the study

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

What is being tested

• Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi (device)

Sponsor: Duke University · Participants: 20 · Started: Oct 15, 2026

Contact the study team

• Birgit Frauscher, MD, PhD · Phone: 919-613-9386
• Bruna Kfoury, Pharm.D. · Phone: 470-312-7573

Official record on ClinicalTrials.gov — NCT07434986

Locations in the U.S.

Conditions

• Temporal Lobe Epilepsy
• Drug Resistant Epilepsy
• Epilepsy

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.