The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

• 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.

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Mary Catherine George, PhD
mary-catherine.george@mssm.edu
212-241-0784
Backup
Toni Kavanagh, NP
toni.kavanagh@mountsinai.org
212-241-2401
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Healthy Participants
Participants with no seizures or suspected temporal lobe seizures.
Experimental: Participants with seizures or suspected temporal lobe seizures
Participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov