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RECRUITING Not applicable ClinicalTrials.gov

Overnight TI in TLE

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07434986

Registry updated: 2026-10-16
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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. 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

Interventions

  • Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi (Device)
    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.

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

Conditions

Temporal Lobe Epilepsy (TLE) Drug Resistant Epilepsy Sleep

Locations

  • Anphy Lab - Inside Hock Plaza — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record