Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
研究概览
简要总结
The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Have given written informed consent
- •Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes.
- •Adults (≥18 years of age)
- •Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study.
- •Experiencing ≥10 seizures per year according to their existing seizure diary.
- •Willing and able to comply with study procedures
排除标准
- •Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures)
- •Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
结局指标
主要结局
Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
时间窗: 6 months
Within-participant correlation between seizure counts per month estimated from rapid review of annotated 24/7 EEG™ SubQ data and 'ground truth' EEG seizure occurrences per month
Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary
时间窗: 6 months
Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month
Clinician rating of accuracy of 24/7 EEG SubQ
时间窗: 6 months
Clinician rating of accuracy of 24/7 EEG SubQ solution
次要结局
- health economic impact of epilepsy for participants compared to historical controls(6 months)
- Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution(6 months)
- EQ-5D-5L score comparison with historical controls(6 months)
- Proportion of treating clinicians changing clinical management(months 1, 2, 3, 4, 5, 6)
- Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ(6 months)
- Participant adherence with 24/7 EEG™ SubQ Solution(6 months)
- Device deficiency(6 months)
- Perceived Self-Mastery Over Epilepsy score(baseline, 2 months and 6 months)
- Perceived Self-Mastery Over Epilepsy score comparison with historical controls(6 months)
- participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution(baseline, 2 months and 6 months)
- Clinical relevance of the 24/7 EEG SubQ solution(baseline, 2 months and 6 months)
- EQ-5D-5L score(baseline, 2 months and 6 months)
- Impact of epilepsy score comparison with historical controls(6 months)
- Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score(baseline, 2 months and 6 months)
- Impact of epilepsy score(baseline, 2 months and 6 months)
- health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution(6 months)
- Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls(6 months)