The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
Icahn School of Medicine at Mount Sinai
Summary
Determine the safety and feasibility of an in-ear device to measure seizures or suspected seizures compared to the standard scalp-based electroencephalogram (EEG). The study team anticipates enrolling five healthy participants through meeting announcements and a research email list serv in the Neurology Dept. Based on the appropriate positive initial test of healthy individuals, test the in-ear device on 10 participants with seizures or suspected seizures scheduled for a clinical scalp EEG test.
Description
SeizEAR aims to develop an in-ear device for the detection, diagnosis, and management of seizures/epilepsy. In the United States, an estimated 1 in 26 people will develop epilepsy within a lifetime, with 60% of all seizures originating in the temporal region of the brain. Electroencephalogram (EEG) is currently the gold standard for seizure detection, measuring electrical activity of the brain via numerous electrodes placed on the scalp. The demand for EEG has been steadily increasing given its higher accessibility and ability to result in substantial changes to patient management. In particul…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Healthy Participants Inclusion Criteria: * Age: \> 18 and \<70 * No History of Seizures or seizure-like activity based on self-report * Normal parameters for vitals, afebrile, blood pressure. * Able to read and write English * Capable of providing informed consent Exclusion Criteria: * History of seizures or seizure-like activity based on self-assessment * Any major health conditions based upon self-report * Concurrent participation in another investigational protocol. * A history of skin sensitivity, or rash on the head, neck or ears. * A history of silver allergy. * Treatment for an ear…
Interventions
- DeviceSeizEAR
The in-ear electrode is a two-electrode device that fits snugly into the ear canal of the user. The device electrodes consist of a Ag/AgCl layer over a substrate. In one iteration, the substrate is a silicone rubber. In another iteration, the substrate is copper. The copper iteration consists of a Ag/AgCl ink that is manually applied to the copper, whereas the other iteration is purchased in a finished state with the Ag/Agel already adhered to the silicone. The electrodes are attached to a foam earpiece during the molding process. The foam earbud is made in-house and can be designed to be more firm or less firm.
Location
- Icahn School of Medicine at Mount SinaiNew York, New York