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SeizEAR Safety Study

Sponsor: Icahn School of Medicine at Mount Sinai • ClinicalTrials.gov ID: NCT07088835

Registry updated: 2026-09-14

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Description

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.

Interventions

SeizEAR (Device)
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.

Eligibility criteria

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 infection in the previous four-week period * Medications that would be contraindicated to participate in the study that would interfere with the EEG Testing Phase 3 Inclusion/Exclusion Criteria: Participants with Seizures or Suspected Temporal Lobe Seizures Inclusion Criteria: * Age \> 18 and \< 70 * Individuals scheduled for clinical EEG for seizures or suspected temporal lobe seizures documented by a neurologist * Stable Health Conditions based upon the principal investigator's opinion * Normal parameters for vitals, afebrile, blood pressure * Able to read and write English * Capable of providing informed consent. Exclusion Criteria: * Any major issues with the skull or ear that would interfere with the EEG testing. * A history of skin sensitivity, or rash on the head, neck or ears * A history of silver allergy. * Treatment for an ear infection in the previous four-week period. * Concurrent participation in another investigational protocol * Any psychiatric disorder (i.e. uncontrolled depression, mood disorders, cognitive impairment, schizophrenia), that complicate measurement of changes associated with the EEG testing.

Conditions

Epilepsy

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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