Acceptability and Impact of Ultra-long-term Subcutaneous EEG Monitoring in People With Epilepsy and Intellectual Disability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Device acceptability
研究概览
简要总结
Many people with intellectual disabilities (PwID) have seizures. Electroencephalography (EEG), which measures the brain's electrical activity, is a key method of diagnosing and assessing seizures but can be difficult and uncomfortable for PwID. UNEEG medical has developed a very small device ('SubQ') that can be put under the skin on a person's head to track their brain activity without staying in the hospital. It has been implanted for 15 months successfully in people with seizures but not in PwID.
The aim of this project is to use learnings from previous co-production work to test how well the device can detect seizures in people with mild to moderate ID and to assess its safety and impact on quality of life and behaviour. The project will also look into carer and clinican experiences using the system and its potential usefulness and cost impact.
Having an accurate means of identifying seizures is particularly important for people with mild to moderate ID because they cannot always tell us about their experiences in a meaningful manner. This means that seizures are more likely to be missed or attributed to behavioural issues.
Healthcare professionals will identify eligible patients to be invited to participate in the study. These patients will be diagnosed with mild to moderate ID, but will have the capacity to consent to take part in the study. The patients who participate in the study will have the UNEEG SubQ device implanted under the skin on their scalp. Ongoing EEG data from the device will be collected and be compared with seizure diaries. The project will also examine any behaviour issues and quality of life using surveys before implantation as well as immediately, 3-months, and 6-months after. The patients, their carers and healthcare professionals will be invited to focus groups to share their experiences with the technology.
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
- •Adults over 18 years old
- •Clinical diagnosis of epilepsy, considered pharmacoresistant
- •Clinical diagnosis of mild to moderate ID based on the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) and the International Statistical Classfication of Diseases and Related Health Problems (11th ed; ICD-11; World Health Organisation, 2022).Patient has the capacity to consent to take part in the study, and does so
- •Able to tolerate the dummy device (device worn for at least 40% of a 1-2 week test period)
- •Family member / carer:
- •Family member/carer is willing to keep a routine seizure diary for the course of the study
- •Retrospective seizure diary data available for the proceeding last 6 months
- •According to family member, carer, or clinical record, the participant is having at least monthly 'episodes of interest' (it may be unclear whether these are epileptic or behavioural episodes)
- •Agree to participate to the study, and support study activities and comply to these
- •Healthcare professional:
- •PwID recommended by their epileptologist for long-term EEG monitoring
- •Agree to participate to the study, and support study activities and comply to these
排除标准
- 未提供
研究组 & 干预措施
Cohort in people with intellectual disability and epilepsy
The target population of the study will include adult patients who are clinically diagnosed with mild to moderate intellectual disability and epilepsy who are recommended for EEG monitoring by their healthcare professional, their family members or carers, and the clinician responsible for their care.
干预措施: A minimally-invasive EEG monitoring device (Device)
结局指标
主要结局
Device acceptability
时间窗: At 6 months post-implantation of the device
The acceptability of the 24/7 SubQ device will be assessed using qualitative data about family members' and carers' perceptions of the patients' experiences with the device. The data will be collected from semi-structured focus groups.
Device adherence
时间窗: Across 6 months post-implantation of the device
The adherence to use of UNEEG SubQ device will be assessed using participants' percentage wear time with 24/7 EEG SubQ.
Device usability
时间窗: At 6 months post-implantation of the device
The usability of the UNEEG SubQ device will be measured using the average score at 6 months (before explantation) on the System Usability Scale (SUS). The SUS is a 5-point Likert scale 10 items, from strongly disagree (score = 1) to strongly agree (score = 5) \[1\].
次要结局
- Device safety(From implantation to explantation of the device)
- Seizure detection accuracy(Across 6 months post-implantation of the device)
- Patients' quality of life(At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation)
- Patient behaviour(At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation)
- Satisfaction with the device in daily activities(At 6 months post-implantation of the device)
- Impact of the device on everyday life(At 6 months post-implantation of the device)
- Impact of the device on epilepsy management plans(At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.)
- Impact of the device on management of epilepsy(At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.)
- Impact of the device on communication with carers(At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.)
- Impact of the device on insights about the patient's epilepsy(At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.)
- Device potential in clinical practice(At 6 months post-implantation of the device)
- Device deficiency(From device implantation until explantation)
研究者
Edward Meinert, PhD
Professor of Digital Health and Clinical Artificial Intelligence
University of Plymouth