Overnight TI in TLE

Study acronym: TI-HPC-TLE
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Recruitment opened Show 6 more changesShow less
    • Start date: Jun 1, 2026 to Oct 15, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 9 of 9 entries
  2. Notable Start date: May 1, 2026 to Jun 1, 2026
    • Primary completion pushed from May 15, 2026 to Oct 30, 2026
    • Study completion pushed from Jun 15, 2026 to Oct 30, 2026
    v3
  3. Notable Start date: Feb 2026 to May 1, 2026v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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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
Trial Details
NCT Number NCT07434986
Lead Sponsor Duke University
Collaborators: St. Anne's University Hospital Brno, Czech Republic
Conditions
(from sponsor)
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep
Related terms Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov