🔎 Trials Near Me

Home › Epilepsy › NCT07088835

SeizEAR Safety Study

RecruitingHealthy volunteers welcome

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

Who can join

Ages 18 to 70 · All sexes · Healthy volunteers welcome

Full 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.

About the study

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.

What is being tested

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 15 · Started: May 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07088835

Locations in the U.S.

New YorkIcahn School of Medicine at Mount Sinai, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.