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Recruiting NCT07088835

SeizEAR Safety Study

Conditions: Epilepsy

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 15
Sponsor: Icahn School of Medicine at Mount Sinai

Location: Icahn School of Medicine at Mount Sinai New York New York

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 \ 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07088835). StuddyBuddy aggregates publicly available trial information.