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Testing a new brain stimulation method in adults with hard-to-control focal epilepsy

Tests a new brain stimulation method in adults with drug-resistant focal epilepsy.

Plain-language title generated from the registry record
Registry title: Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring

Key facts

Where
Durham, United StatesSee the site

Where in United States

  • Duke University Medical CenterDurham, United StatesTaking people

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Trial details

Who runs it
Duke University
Trial code
NCT07764718
Record updated
15 October 2026
Original description
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.Read full original descriptionShow less

Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy

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.

Inclusion: Adult patients with focal DRE who will undergo presurgical evaluation with sEEG; Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes; sEEG performed with the indication to identify one single epileptic focus; Ability to provide written informed consent and comply with the study protocol.

Exclusion: Remote resective/ablative brain surgery.

ClinicalTrials.gov NCT07764718