SeizEAR Safety Study

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство SeizEAR
  The in-ear electrode is a two-electrode device that fits snugly into the ear canal of the user. The device electrodes consist of a Ag/AgCl layer over a substrate. In one iteration, the substrate is a silicone rubber. In another iteration, the substrate is copper. The copper iteration consists of a Ag/AgCl ink that is manually applied to the copper, whereas the other iteration is purchased in a finished state with the Ag/Agel already adhered to the silicone. The electrodes are attached to a foam

Первичные конечные точки

• Sensitivity [Срок оценки: at week 16]
• F1 score [Срок оценки: at week 16]
• Positive predictive value (PPV) [Срок оценки: at week 16]
• False detection rate [Срок оценки: at week 16]
• Comfort Rating Scale [Срок оценки: at week 16]

Критерии участия

Healthy Participants

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07088835 · STUDY-24-00433 · GCO 21-1216

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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