NCT07434986 · Duke University
Overnight TI in TLE
(TI-HPC-TLE)
What this study is about
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.
View original scientific 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: 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.
Interventions
DEVICE
Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
Non-invasive temporal interference (TI) electrical stimulation delivered overnight to target the bilateral hippocampi during in-laboratory polysomnography and scalp EEG monitoring. Stimulation is applied via a multi-channel, current-controlled stimulator using a scalp electrode montage planned with MRI-guided modeling. TI is delivered continuously from lights-off to lights-on for three consecutive nights, with gradual ramp-up and ramp-down at the start and end of each session. Stimulation parameters use kilohertz carrier currents arranged to produce an amplitude-modulated envelope at 130 Hz at each hippocampal target, with current adjusted within preset safety limits based on tolerability and impedance.
Primary outcome measures
Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG
Time frame: Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period).
Overnight interictal epileptiform discharge (IED) rate (spikes per minute) computed from scalp EEG during sleep. IEDs will be identified using a standardized scoring pipeline, and the rate will be calculated as total IED count divided by total minutes of sleep (PSG-defined sleep time). Lower values indicate fewer epileptiform discharges (improvement). The primary comparison is baseline no-stimulation night versus the average of the active TI stimulation nights.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Collaborators
St. Anne's University Hospital Brno, Czech Republic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations