Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy (EE-DES-TIEF)
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
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brno, Czechia
- St. Anne Hospital, Masaryk University
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California
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Sacramento, California, United States, 95817
- UC Davis Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing invasive intracranial EEG studies
Exclusion Criteria:
- None
Study Plan
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 |
|---|---|
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Experimental: Temporally-Interfering Electrical Field Central Nervous System Stimulation
Participants in this arm receive temporally-interfering electric fields stimulation.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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).
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2042345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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