NCT01850498已完成不适用
Motion Sensing Study in Epilepsy Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings).
研究概览
简要总结
Evaluate patient motion during seizures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
- •Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
- •Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
- •Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
- •Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
- •Male or non-pregnant female
- •English speaking
排除标准
- •Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
- •Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
- •Have a movement disorder that may affect GT3X+ recordings
结局指标
主要结局
To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings).
时间窗: While patients are being evaluated in an epilepsy monitoring unit.
次要结局
- Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings).(While patients are being evaluated in an epilepsy monitoring unit.)
- Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings).(While patients are being evaluated in an epilepsy monitoring unit.)
- Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings).(While patients are being evaluated in an epilepsy monitoring unit.)
研究者
研究点 (1)
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