NCT06716866

Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	temporally-interfering electric field stimulation	Temporally-interfering electric field stimulation is a candidate non-invasive means to stimulate and modulate the nervous system. We do not know of any other trials of this method in epilepsy patients.

Timeline

• Start date: 2019-01-16
• Primary completion: 2030-07-01
• Completion: 2030-07-01
• First posted: 2024-12-04
• Last updated: 2025-07-20

Locations

3 sites across 2 countries: United States, Czechia

Regulatory

• FDA-regulated device study