Overnight TI in TLE (NCT07434986) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Overnight TI in TLE
United States20 participantsStarted 2026-06-01
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).