Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 15, 2026 to Sep 16, 2026
    • Secondary endpoints: details revised at 2 of 3 entries
    • Eligibility criteria expanded, about 4 words
  2. 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.
Duke University
457 trials monitored
See 58 trials at risk
Epilepsy
776 trials monitored
See 49 trials at risk
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.
Trial Details
NCT Number NCT07764718
Lead Sponsor Duke University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Drug-Resistant Focal Epilepsy
Related terms Drug Resistant Epilepsy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov