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

Duke University

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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

Interventions

Device
Temporal Interference Stimulation
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.
Device
Direct Electrical Stimulation
Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.

Location

Duke University Medical Center
Durham, North Carolina
birgit.frauscher@duke.edu 919-597-1523

Summary

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

Detailed criteria

Interventions

Device

Temporal Interference Stimulation

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.

Device

Direct Electrical Stimulation

Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.