Determination of Efficacy of Sustained Motor Contraction Generated Using StimWave Peripheral Nerve Stimulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- MRC grade
研究概览
简要总结
Paralysis is one of the most disabling features of Spinal cord injury and stroke. In select cases, where the nerve is intact, stimulation can achieve meaningful muscle contraction e.g. to restore grip and release function. Previously, products to serve this purpose had been developed and successfully implanted (Freehand device). However, they had technical and cost limitations and have gone out of production.
We aim to investigate if a simple implantable and commercially available system could replicate the same function.
Patients implanted with a wireless peripheral nerve stimulation (PNS) system for chronic pain in the upper limb shall be identified and approached for consent. Surface electromyography (EMG, baseline and with active contraction) shall be performed to confirm intact motor nerves. Baseline MRC (Medical Research Council Scale for Muscle Strength) grade shall be assessed. PNS shall be programmed to produce muscle contraction (within FDA approved safe limits for the device) with the EMG monitoring. The muscle contraction shall be recorded on video for further evaluation. Strength of contraction shall be assessed on the MRC scale. Stimulation parameters shall be then re-adjusted to pain-relief setting. Neurological examination shall be performed and return to baseline EMG ascertained.
Data shall be analysed and the Study shall end when the data for the last participant shall be gathered.
详细描述
Paralysis is one of the most disabling features of Spinal cord injury and stroke. In select cases, where the nerve is intact, stimulation can achieve meaningful muscle contraction e.g. to restore grip and release function. Previously, products to serve this purpose had been developed and successfully implanted (Freehand device). However, they had technical and cost limitations and have gone out of production. This concept of functional electrical stimulation has also been utilised with external orthoses, however the applicability has been limited both due to the precision required in applying the external device each time and the need of someone else to put this on, defeating the purpose.
We aim to investigate if a simple implantable and commercially available system could replicate the same function. Curonix (formerly StimWave) wireless PNS is one such system that is already CE marked and FDA approved for stimulation of peripheral nerves. It is currently used for stimulation of peripheral nerves for pain relief.
During programming for the same, to check for adequate placement, motor stimulation is routinely performed which elicits corresponding muscle twitch. Even though the parameters are approved for safety, it has not been used to generate a clinically meaningful sustained muscle contraction.
Patients implanted with a wireless peripheral nerve stimulation (PNS) system for chronic pain in the upper limb shall be identified and approached for consent. Surface electromyography (EMG, baseline and with active contraction) shall be performed to confirm intact motor nerves. Baseline MRC (Medical Research Council Scale for Muscle Strength) grade shall be assessed. PNS shall be programmed to produce muscle contraction (within FDA approved safe limits for the device) with the EMG monitoring. The muscle contraction shall be recorded on video for further evaluation. Strength of contraction shall be assessed on the MRC scale. Stimulation parameters shall be then re-adjusted to pain-relief setting. Neurological examination shall be performed and return to baseline EMG ascertained.
Data shall be analysed and the Study shall end when the data for the last participant shall be gathered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking as both participants and investigators will be aware of the intervention.
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
- •Male or Female, aged 18 years or above with implanted Curonix (formerly: Stimwave) PNS for radial, ulnar or median nerve;
- •Functioning lower motor neuron (LMN) pathway determined by baseline EMG.
排除标准
- •Age <18yr;
- •Myopathy and other LMN disorders;
- •Impaired LMN pathway determined by EMG.
研究组 & 干预措施
Intervention Arm
Participants receiving stimulation to elicit muscle contraction.
干预措施: Stimulation of the motor unit (Procedure)
结局指标
主要结局
MRC grade
时间窗: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.
Medical Research Council (MRC) Scale for Muscle Strength shall be assessed before the intervention, with the intervention ongoing and after it is completed. The MRC scale is as follows: Grade 5: Normal strength Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb Grade 0: No visible contraction The difference between active (baseline) muscle contraction and contraction achieved with the device shall be calculated.
EMG
时间窗: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.
Surface, non-invasive EMG shall be performed to assess the selected muscle before the intervention, with the intervention ongoing and after it is completed. The assessed parameter is the amplitude \[μV\]. The difference between active (baseline) muscle contraction and contraction achieved with the device shall be calculated.
次要结局
未报告次要终点