SeizEAR: in-ear device for detecting seizures
The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
NA · Icahn School of Medicine at Mount Sinai · NCT07088835
This project will test whether a small in-ear device can safely detect seizures in adults first without epilepsy and then in people undergoing clinical scalp EEG for suspected temporal-lobe seizures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07088835 on ClinicalTrials.gov |
What this trial studies
SeizEAR is developing an in-ear sensor designed to record brain electrical activity as an alternative to scalp EEG. The study will first enroll five healthy adult volunteers to test safety and basic signal quality, then enroll about ten adults who are scheduled for clinical scalp EEG for suspected temporal-lobe seizures to compare signals simultaneously. Investigators will compare the in-ear recordings to standard scalp EEG to see if the device can capture seizure-related activity and to document any device-related adverse events. The goal is to determine feasibility, comfort, and basic performance before larger clinical testing.
Who should consider this trial
Good fit: Ideal participants are adults aged 18–69 who are either healthy volunteers without a history of seizures for initial safety testing or patients scheduled for clinical scalp EEG for suspected temporal-lobe seizures.
Not a fit: People with active ear infections, known silver allergy, skin sensitivities of the head/ears, children, or those with non–temporal-lobe seizure types are less likely to benefit from this device in its current testing phase.
Why it matters
Potential benefit: If successful, the device could provide a more comfortable, lower-cost, technician-free way to detect and monitor temporal-lobe seizure activity and improve access to EEG-like monitoring.
How similar studies have performed: Prior pilot work and early reports of intra-ear monitoring have suggested intra-ear recordings can detect seizure-related activity, but the specific SeizEAR device and full clinical validity remain novel and incompletely tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Ho Wing (Andy) Chan, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Mary Catherine George, PhD
- Email: mary-catherine.george@mssm.edu
- Phone: 212-241-0784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Intracranial Electroencephalogram, Seizures, In Ear Device to Detect Seizures, Temporal Lobe, Brain Waves