Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy

NCT06716866 | Enrolling By Invitation FDA Device

• 1 other identifier: 2042345
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Epilepsy

Keywords

temporally-interfering electric fields

Outcome Measures

Primary Outcomes (1)

• Reduction of Interictal Biomarkers of Epilepsy

  Three epilepsy interictal biomarkers will be examined: Interictal epileptiform discharges (IEDs), pathologic ripples (PRs), and high-frequency oscillations (HFOs). Each is recorded from intracranial field potential recordings (also 'intracranial electroencephalography' or iEEG). IEDs can also be recorded from scalp EEG where this is available (it is typically not recorded during iEEG studies). These features of the intracranial EEG will be measured at baseline, during sham TIEFS, and during active TIEFS. The primary outcome is the change in the number of IEDs during the baseline, sham, or active TIEFS periods. The secondary outcome is the number of PRs and HFOs during these periods. Semi-automated detection of IEDs, PRs, and HFOs will be performed using the freely available and validated AnyWave software ( INSERM and Aix-Marseille University) and its 'Delphos' detector. IEDs, PRs, and HFOs rates per minute will be determined.

  From enrollment until the end of the admission for each patient (the admission is typically 7-14 days in duration).

Study Arms (1)

Temporally-Interfering Electrical Field Central Nervous System Stimulation

EXPERIMENTAL

Participants in this arm receive temporally-interfering electric fields stimulation.

Device: temporally-interfering electric field stimulation

Interventions

temporally-interfering electric field stimulation DEVICE

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.

Also known as: temporal interference electric field stimulation

Temporally-Interfering Electrical Field Central Nervous System Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing invasive intracranial EEG studies

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, Davis: lead
• Emory University: collaborator
• St. Anne's University Hospital Brno, Czech Republic: collaborator
• Semmelweis University: collaborator
• Hôpital de la Timone (MARSEILLE): collaborator

Study Sites (3)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St. Anne Hospital, Masaryk University

Brno, Czechia

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: December 4, 2024
• Study Start: January 16, 2019
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At the completion of the studies.
• Access Criteria: Data will be shared upon request to the investigative team for non-commercial and academic use.

Locations

US (2); CZ (1)