SeizEAR Safety Study
Icahn School of Medicine at Mount Sinai · NCT07088835
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–70 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 15
- US sites recruiting
- 1
- Study start
- May 8, 2025
- Record last updated
- September 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: SeizEAR
Conditions: Epilepsy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Icahn School of Medicine at Mount Sinai
New York, NY 10029
Study contacts (from the official record)
- Mary Catherine George, PhD · 212-241-0784 · mary-catherine.george@mssm.edu
- Toni Kavanagh, NP · 212-241-2401 · toni.kavanagh@mountsinai.org
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