Micro-EMG: A Novel Multi-electrode System for Intramuscular Imaging of Human Motor Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Report of tested and potential vs. disregarded diagnostic markers for MicroEMG.
研究概览
简要总结
The purpose of this small-scale exploratory study is to bridge the knowledge gap between the bench testing and the design of potential future confirmative studies. Identifying and evaluating MicroEMG measurement parameters in this exploratory manner is a necessary step to evaluate its usability and design, and determine whether the microEMG system may be suitable for in-house use after further confirmative testing.
详细描述
About this study We have developed a completely new multi-electrode electromyography system (MicroEMG) that we want to test in this study. It records muscle activity from multiple recording points in the muscle at once. We believe that this will increase the sensitivity of the technique in diagnosing muscle disease, reduce the time taken, and be more comfortable for patients. However, to prove whether this is the case we first need to understand the how the recorded signals of the new MicroEMG look like in different patient groups.
Background:
Why are we doing this study?
Electromyography (EMG) is an essential diagnostic test for nerve and muscle diseases. Cells in the muscle generate electric potentials when they are activated. This activity can be measured by the EMG. Based on those 'patterns', experts can detect medical abnormalities, such as muscle or nerve disorders. EMG involves inserting a thin metal needle electrode through the skin into a muscle. It records changes in the pattern of electrical signals produced by the muscle fibres. In conventional EMG only a single recording surface at the tip of the needle is used and therefore only small part of muscle can be examined.
We developed a new EMG device called MicroEMG. It uses a novel type of electrode that can examine the muscle in more detail. As it records activity from several different points at the muscle at once it can produce an electrical image (rather than an abstract signal). This way a large volume of muscle can be recorded simultaneously with less movement and discomfort for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For each of the five groups, six participants will be recruited, adding up to a total of 30 participants.
排除标准
- •cardiac pacemakers or defibrillator implants.
- •alternative neurological disorders likely to affect the results of an EMG examination.
- •lymphedema or dialysis fistula in the body region to be studied with EMG.
- •patients taking clotting inhibitor (such as warfarin or direct oral anticoagulants).
- •clotting disorder (such as haemophilia or low platelets).
- •participants unable to consent in English where a translator is not available.
结局指标
主要结局
Report of tested and potential vs. disregarded diagnostic markers for MicroEMG.
时间窗: 1 study day
extracted from EEG recordings
List of potential EMG parameters to inform future diagnostic marker evaluation studies.
时间窗: 1 study day
extracted from EEG recordings
次要结局
- Summary of health care and patient experience with MicroEMG system.(1 study day)
- Potential changes to the system or the examination procedure.(1 study day)