SeizEAR Safety Study

ID#: NCT07088835

Age: 18 - 70 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Enrolling by invitation

Start Date: May 08, 2025

End Date: October 31, 2025

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: 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.
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