NCT07434986Recruiting
Overnight TI in TLE
Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Duke University
- Diseases
- Epilepsy
- NCT number
- NCT07434986
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 15 Oct 2026 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Implanted electronic or metallic devices incompatible with TI (e.g., certain pacemakers, cochlear implants) as per device manual
- Concurrent enrollment in other interventional neuromodulation or pharmacological trials likely to confound EEG or sleep outcomes
Other illness
- 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)
- Dermatologic disease at electrode sites or known contact allergy to electrode materials
Other
- Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anphy Lab - Inside Hock Plaza Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.