Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: temporally-interfering electric field stimulation.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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).]
Eligibility criteria
Inclusion criteria
- Patients undergoing invasive intracranial EEG studies
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- UC Davis Medical Center — Sacramento
- Emory University Hospital — Atlanta
Czechia · 1 center
- St. Anne Hospital, Masaryk University — Brno
Identifiers
NCT: NCT06716866 · 2042345