Clinical Validation of zEEG, a Wireless EEG Recording System for Pediatric and Adult Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Technical equivalence
研究概览
简要总结
The purpose of this study is to compare the standard clinical electroencephalography (EEG) device with a new portable wireless EEG device, further referred to as zEEG, made by ZETO®. zEEG was designed to make EEG studies simpler, safer, more comfortable, faster, and less obstructive for the patient, also easier to set up for technicians. Wireless and battery powered, it uses the latest mobile technology. Contrary to the clinical EEG, this headset does not use any glue between the skin and the electrodes. Minor skin irritation may still occur but much less likely than from the collodion glue used in the clinical electrodes. In addition, the zEEG system does not need any gel to be applied to the skin. The zEEG electrodes are dry and disposable. They have never been used on any other head before. No additional risk is involved with setting it up. In addition to the clinically necessary EEG electrodes or intracranial electrodes for long term monitoring, we will place zEEG on the head to compare the sensitivity of the new device to the traditional device. zEEG is proven to meet the standard of clinical system and received an FDA clearance in 2018. If further clinical tests validate its technical parameters and comfort, it may replace traditional clinical EEG systems.
详细描述
Research Hypothesis:
The hypothesis is that signals recorded by zEEG do not differ significantly from signals recorded by a standard clinical EEG system (clinical EEG). In this study we will use the Xltek® (Natus, Inc.) clinical-grade FDA-approved long-term video monitoring EEG system and the Nicolet ® (Natus, Inc.) clinical-grade FDA approved ambulatory EEG system. zEEG will be compared against both systems. Minor difference in signal is expected due to the non-overlapping positions of the 6 electrodes. The 1-2 cm position difference between the electrodes is expected to generate discernible difference between the two signals.
Background:
The purpose of the study is to validate the zEEG® by ZETO, Inc. (zEEG), a wearable wireless headset and data acquisition (DAQ) system on both pediatric and adult patient populations diagnosed with epilepsy. The study compares (i) the technical parameters of the two systems, (ii) the sensitivity and specificity of the zEEG against standard clinical EEG DAQ systems used for detecting abnormal epileptiform discharges, (iii) the correlation with intracranial recordings, (iv) and the discriminability of the two systems by trained neurologists in a double-blind paradigm. Since zEEG device has received a 510(k) clearance from FDA in 2018, the study does not concern with the safety of the device. The device poses no significant risk, as evaluated by the FDA, and qualifies as Class II category. The goal of the study is to evaluate the utility of a dry, easy to use, wireless system in clinical electrography by a quantitative assessment of the overall quality of the signal relative to a traditional clinical EEG system.
Design and methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of simple and multifocal seizure or generalized seizure who are at least 1 year old but 19 years old at most, whose head the zEEG headset fits, and who also produced sufficient seizure and normal activity EEG data. This age range is all-inclusive, because the actual patient selection will be based on the head-sizes that the zEEG system will fit to.
排除标准
- •Patients younger than 1 year and older than 19 years, pseudo seizures, patients who did not generate normal EEG data or their EEG electrode setting is in conflict with the zEEG headset will be excluded. Patients who cannot keep the zEEG headset on their head will be excluded.
结局指标
主要结局
Technical equivalence
时间窗: 2022-2023
Equivalence of signal to noise ratio of EEG signal
次要结局
- Clinical equivalence(2022-2023)