CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- BioSerenity
- 主要终点
- Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.
研究概览
简要总结
The proposed study is designed to evaluate the performance of the Neuronaute in comparison with the gold standard EEG in patients with a regular appointment at the hospital. The design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed.
Volunteers will be asked to participate to this study. This study will enroll 35 outpatient subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study.
Patients will be submitted to the studied device record Neuronaute following by the gold standard EEG.
A grid with all EEG activity recorded during the trial will be provided for evaluation after completion of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, with a regular appointment to perform an EEG recording: (i) suspected of epileptic disorders or (ii) epilepsy already diagnosed.
- •Age (> 18 years),
- •Affiliated to the social security
- •Informed consent.
排除标准
- •No informed consent
- •Age (< 18 years)
- •No affiliation to the social security
- •Unsuitable anthropometric parameters
- •Pregnant women
- •Recent brain surgery
- •Wound or scores on the body and the scalp
- •Ongoing participation in another clinical trial
- •Allergy to any component from MD including : Silver, polyamide, silicone
- •Sensory disorders making the patient insensitive to pain on the skin
- •Behavioral disorders making the patient excessively agitated or aggressive;
- •Motor or mental disorders preventing the patient from expressing his or her pain;
- •Cardiorespiratory disorders likely to be aggravated by slight compression of the chest;
- •The susceptibility to tension headaches (the compression exerted by the bonnet may in certain cases trigger a headache)
结局指标
主要结局
Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.
时间窗: 1 year
The main evaluation criteria is the reproducibility based on the interpretation of electroencephalographic signals recorded by the Neuronaute compared to the gold standard. The system will be considered effective if there are no significant differences in the physiological parameters recorded by the two systems. A clinical expert will interpret the EEG(electroencephalography) signals and fill the EEG evaluation sheet. It includes items such as signals quality and presence of abnormal events
次要结局
- The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.(1 year)
- The Neuronaute will be considered efficient if the installation time is at least as fast as the installation of the gold standard. The time will be measured from the beginning of the patient's preparation until the beginning of the recording.(2 hours)
- The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.(1 year)