Actively Recruiting
SeizEAR Safety Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-23
15
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
SeizEAR Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 and less than 70 years
- No history of seizures or seizure-like activity (for healthy participants)
- Normal vital signs, afebrile, and stable blood pressure
- Able to read and write English
- Capable of providing informed consent
- Individuals scheduled for clinical EEG for seizures or suspected temporal lobe seizures documented by a neurologist (for seizure participants)
- Stable health conditions as assessed by the principal investigator (for seizure participants)
You will not qualify if you...
- History of seizures or seizure-like activity (for healthy participants)
- Any major health conditions based on self-report
- Concurrent participation in another investigational protocol
- History of skin sensitivity, rash on the head, neck, or ears
- History of silver allergy
- Treatment for an ear infection within the previous four weeks
- Medications interfering with EEG testing
- Any major skull or ear issues interfering with EEG testing (for seizure participants)
- Any psychiatric disorders complicating EEG measurement (e.g., uncontrolled depression, mood disorders, cognitive impairment, schizophrenia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Mary Catherine George, PhD
CONTACT
T
Toni Kavanagh, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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