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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07764718

Registry updated: 2026-10-15
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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.

Interventions

  • Temporal Interference Stimulation (Device)
    Non-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus.
  • Direct Electrical Stimulation (Device)
    Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.

Eligibility criteria

Inclusion Criteria: * 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 Criteria: \- Remote resective/ablative brain surgery

Conditions

Drug-Resistant Focal Epilepsy

Locations

  • Duke University Medical Center — 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