| NCT ID | NCT07434986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Temporal Lobe Epilepsy (TLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10-15 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-10-15 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Birgit Frauscher, MD / PD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07434986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Temporal Lobe Epilepsy (TLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434986 currently recruiting?
Yes, NCT07434986 is actively recruiting participants. Contact the research team at birgit.frauscher@duke.edu for enrollment information.
Where is the NCT07434986 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07434986 clinical trial?
NCT07434986 is sponsored by Duke University. The principal investigator is Birgit Frauscher, MD / PD at Duke University. The trial plans to enroll 20 participants.
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