Epilepsy
Conditions
Keywords
temporally-interfering electric fields
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.
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
DEVICEtemporally-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.
Sponsors
University of California, Davis
Emory University
St. Anne's University Hospital Brno, Czech Republic
Semmelweis University
Hôpital de la Timone (MARSEILLE)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing invasive intracranial EEG studies
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Interictal Biomarkers of Epilepsy | 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. |
Countries
Czechia, United States
Outcome results
None listed