Study to Validate Novel Seizure-Detection Algorithm
关键词
抽象
描述
Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.
Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.
This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.
日期
| 最后验证: | 01/31/2020 |
| 首次提交: | 02/23/2020 |
| 提交的预估入学人数: | 02/26/2020 |
| 首次发布: | 03/01/2020 |
| 上次提交的更新: | 02/26/2020 |
| 最近更新发布: | 03/01/2020 |
| 实际学习开始日期: | 02/29/2020 |
| 预计主要完成日期: | 09/30/2020 |
| 预计完成日期: | 11/30/2020 |
状况或疾病
干预/治疗
Device: Single Arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: Single Arm This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU. | Device: Single Arm A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU). 4. Male or female. 5. Aged 18 and above. 6. The patient has experienced at least one generalized major motor seizure prior to admission. 7. Agreement to wear a wristwatch throughout the duration of the study on the left wrist. 8. Ability to cancel false positive alarms via interaction with the application on the watch. Exclusion Criteria: 1. Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures). 2. Known allergic reactions to components of the (watch materials). 3. Treatment with another investigational drug or other intervention within the study 4. Children under the age of 18. 5. Women who are pregnant or nursing. 6. Inability to give consent to the study. 7. Active skin infection or rash on the upper extremities |
结果
主要结果指标
1. Sensitivity [1 to 5 days]
次要成果指标
1. False positive rate [1 to 5 days]
2. Mean detection latency [1 to 5 days]
3. Notifications [1 to 5 days]
4. Cancellations [1 to 5 days]
