SeizEAR Safety Study

Mount Sinai Health System

Status: Enrolling

Conditions: Epilepsy

Treatments: Device: SeizEAR

Study type: Interventional

Funder types: Other

Identifiers

NCT07088835

STUDY-24-00433

GCO 21-1216 (Other Identifier)

Details and patient eligibility

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.

Full description

SeizEAR aims to develop an in-ear device for the detection, diagnosis, and management of seizures/epilepsy. In the United States, an estimated 1 in 26 people will develop epilepsy within a lifetime, with 60% of all seizures originating in the temporal region of the brain. Electroencephalogram (EEG) is currently the gold standard for seizure detection, measuring electrical activity of the brain via numerous electrodes placed on the scalp. The demand for EEG has been steadily increasing given its higher accessibility and ability to result in substantial changes to patient management. In particular, pre-surgical evaluation of seizure was studied in the ambulatory setting, with good post-resection outcomes in selected patients with unilateral temporal lobe epilepsy. The EEG technology requires substantial technician training, can lead to patient discomfort, and still incurs high patient costs (roughly 500-3,000$ per order). Furthermore, current EEG interpretation can be complicated by high rates of false detection and poor sensitivity, as signals may be impeded by scalp conditions, the use of hair products, and other concomitant medical devices. SeizEAR will offer a technician-free, easy to use, comfortable, and cost-effective alternative to seizure monitoring. Intra-ear monitoring has been shown to permit real-time detection of seizure activity and allow for prolonged monitoring of abnormal (inter-ictal) discharges. Intra-ear monitoring is particularly suitable for temporal lobe epilepsy, given the proximity of the ear canal to the temporal lobe of the brain. Prior studies have demonstrated that intra-ear monitoring of temporal brain activity can reliably detect temporal lobe seizures with the added benefit of limiting ocular artifact, a common confounder of more traditional scalp EEG. Collaborating with the industry partner, Starkey Hearing Technologies, the researchers aim to prototype SeizEAR with two electrodes targeting the temporal lobe, wired to a signal processor/box. The objective will be to demonstrate the safety and efficacy of a first-generation SeizEAR device to monitor brain waves in healthy controls and participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG. Long term, the goal will be to validate the clinical efficacy of SeizEAR in detecting seizures

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Healthy Participants

Experimental group

Description:

Participants with no seizures or suspected temporal lobe seizures.

Treatment:

Device: SeizEAR

Participants with seizures or suspected temporal lobe seizures

Experimental group

Description:

Participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG.

Treatment:

Device: SeizEAR