Overnight Stimulation Through the Skin for Drug-Resistant Temporal Lobe Epilepsy
Tests overnight skin stimulation of the hippocampus in adults with temporal lobe epilepsy.
Plain-language title generated from the registry record
Registry title: Overnight TI in TLE
Key facts
- Where
- Durham, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07434986, who can take part
Where in United States
- Anphy Lab - Inside Hock PlazaDurham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT07434986
- Record updated
- 16 October 2026
- Original description
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:Read full original descriptionShow less
Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
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
Inclusion: 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: 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; 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; Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated; Pregnancy or breastfeeding.