Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy (EE-DES-TIEF)

July 16, 2025 updated by: University of California, Davis

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing invasive intracranial EEG studies

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporally-Interfering Electrical Field Central Nervous System Stimulation
Participants in this arm receive temporally-interfering electric fields stimulation.
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.
Other Names:
  • temporal interference electric field stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Interictal Biomarkers of Epilepsy
Time Frame: From enrollment until the end of the admission for each patient (the admission is typically 7-14 days in duration).

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Emory University
Semmelweis University
St. Anne's University Hospital Brno, Czech Republic
Hôpital de la Timone (MARSEILLE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2042345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD will be shared with other researchers at the completion of the study.

IPD in this study consists of the anatomical location of electrode contacts, electrophysiological recordings, field models of the carrier fields and interference envelope. IPD also includes neuroimaging, and key data from the clinical neurophysiology reports.

All data will be fully de-identified.

IPD Sharing Time Frame

At the completion of the studies.

IPD Sharing Access Criteria

Data will be shared upon request to the investigative team for non-commercial and academic use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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