Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Nigel P. Pedersen, BSc MBBS (ucdavis)

Description

Summary

This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy. In this case series within and between subjects design, the impact of TIEFS on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy.

Secondary analyses examine the underlying physiological effects of TIEF on local brain activity and brain networks.

Official Title

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

Details

Participants Patients with drug-resistant focal epilepsy and a clinical diagnosis of medial temporal epilepsy undergoing invasive intracranial electrophysiology studies will be consented in accord with institutional review boards at Emory University, Saint-Anne University Hospital, and the Institute of Neurosurgery and Neurointervention, Semmelweis University. The determination of medial temporal epilepsy is based on clinical semiology, EEG, PET, MRI, and invasive electrophysiology. Across all centers, patients underwent the stimulation protocols 6 to 10 days post-implantation after patient-specific electric field modeling to determine TIEFS electrode placement.

Patients then undergo two sessions of TIEFS on separate days, one sham (aligned carriers), and one active (with an offset in frequency between the carriers to provide a lower-frequency modulation envelope at the anatomical target.

Keywords

Epilepsy, temporally-interfering electric fields, temporally-interfering electric field stimulation, Temporally-Interfering Electrical Field Central Nervous System Stimulation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients undergoing invasive intracranial EEG studies

You CAN'T join if...

  • None

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Emory University Hospital
    Atlanta Georgia 30322 United States
  • St. Anne Hospital, Masaryk University
    Brno Czech Republic

Lead Scientist at University of California Health

  • Nigel P. Pedersen, BSc MBBS (ucdavis)
    Associate Professor, Med: Neurology, School of Medicine. Authored (or co-authored) 22 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06716866
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated