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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Temporal Interference Stimulation
  • Direct Electrical Stimulation

Treatment groups

30 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Duke University

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator