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Recruiting NCT07088835

SeizEAR Safety Study

Trial Parameters

Condition Epilepsy
Sponsor Icahn School of Medicine at Mount Sinai
Study Type INTERVENTIONAL
Phase N/A
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-05-08
Completion 2026-12-31
Interventions
SeizEAR

Brief 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.

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

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