SeizEAR Safety Study

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jul 25, 2025

Keywords

ClinConnect Summary

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 parti...

Gender

ALL

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.