Investigation Into the Efficacy and Application of Non-invasive Sensor Technology to Produce a Community-based Seizure Alarm/Monitor for Epilepsy and Episodic Hyperexcitability Disorders.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Measurable changes in muscle tonicity specific to and discernable seizure activity
研究概览
简要总结
Epilepsy is an episodic disorder which can result in recurrent seizures often associated with hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia can often occur before full expression of the seizure and so detection of hypertonia could act as an alarm to epilepsy patients and carers in order to prepare for a seizure event. Secondly, a recording device for seizure frequency and duration is a valuable clinical tool for collecting data for clinicians who manage the disorder in primary and tertiary care. The investigators have developed a portable prototype for hypertonia detection using a non-invasive, muscle activated, sensor that records seizure activity. The investigators now want to test this sensor system in patients identified by Consultant Clinician Custodians within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For phase 1 of the trial; - admission to the neurophysiology department at Morriston hospital for in patient video telemetry
- •For Phase 2 of the trial:
- •For PG-1 and PG-2 the persistence of intractable tonic-clonic epilepsy
- •For PG-3 the clinical suspicion of dissociative seizures
- •For PG-4 the clinical diagnosis of absence epilepsy
- •For CG-1 the absence of neurological, muscular-skeletal disorders
- •Suitable circumstances for informed consent in all instances
排除标准
- •For Phase 1 of the trial:
- •a diagnosis of a movement disorder
- •For Phase 2 of the trial
- •Where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in PG-
- •Where neurological diagnosis is ambiguous or incomplete.
- •Where topical application of the sensors causes discomfort or psychological distress.
结局指标
主要结局
Measurable changes in muscle tonicity specific to and discernable seizure activity
时间窗: 2 years
The primary outcome measure for the study will the development of a tonicity monitor that can successfully detect increases in muscle tonicity preceding a seizure event and alert the patient of an impending attack.
次要结局
- Using the device to reliably measure seizure frequency(2 years)
- Using the device to reliably measure seizure duration(2 years)
- Using the device to reliably measure strength of seizure(2 years)