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