Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Location of evoked sensations
研究概览
简要总结
Neuropathy refers to a condition that results from damage to the peripheral nerves.The most common cause of it is diabetes mellitus, metabolic disorder that affects more than 422 million individuals worldwide, putting a huge strain on the healthcare system and up to 50% of these individuals will develop neuropathy. Peripheral neuropathy is characterized by sensory nerve abnormalities such as an impaired sense of touch. Sensory loss in feet can lead to functional deficits during gait, low balance, and increased risk of falls and is considered the strongest risk factor for diabetic foot ulceration. Moreover, these patients usually also suffer from neuropathic pain, which is believed to be associated with aberrant sensory input.
With this in mind, the study aims to understand the effects of restoring sensation lost to neuropathy using transcutaneous electrical stimulation. Additionally, the investigators aim to understand if electrical stimulation of the damaged nerves can reduce health consequences such as chronic pain.
To achieve this, the investigators have developed a wearable sensory restoration system that can restore lost sensation with non-invasive, precisely controlled electrical stimulation through electrodes integrated into the sock garment. A system is composed of a system controller that communicates via Bluetooth with force-sensitive insoles placed in the shoes and neurostimulators directly connected to electrode array socks. Based on the insole recordings the stimulation parameters are defined in real-time, making it a closed-loop system for restoring somatotopic sensory feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosed polyneuropathy
- •Ability to stand and walk unassisted.
- •Sensory loss in the feet
排除标准
- •Open ulcers on the feet
- •Pregnancy
- •History of or current psychological diseases that include schizophrenia and major depression
- •Hypersensitivity to electrical stimulation
结局指标
主要结局
Location of evoked sensations
时间窗: through study completion, an average of 2 weeks
Document where on the feet the subject perceives the stimulation locations.
Stimulation threshold range to a variety of stimulus parameters
时间窗: through study completion, an average of 2 weeks
Quantify the lower and higher threshold (charge) stimulus eliciting somatosensory sensation
Safety of the participants
时间窗: up to 1.5 months
Number of adverse events possibly, probably or causally related to the procedure or device
次要结局
- Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment(up to 1.5 month)
- Impact of providing sensory feedback on volume of oxygen (VO2) consumption (metabolic consumption) during walking(through study completion, an average of 2 weeks)
- Treatment Satisfaction Measure(through study completion, an average of 2 weeks)
- Impact of providing somatosensory feedback on mobility(through study completion, an average of 2 weeks)
- Impact of providing sensory feedback on dual-task gait assessment(through study completion, an average of 2 weeks)
- Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment and before and after each session(up to 1.5 month)
- Impact of providing sensory feedback on tactile acuity(through study completion, an average of 2 weeks)
- Impact of providing sensory feedback on sensitivity (Quantitative sensory testing)(through study completion, an average of 2 weeks)
- Impact of providing superficial stimulation on feet swelling(through study completion, an average of 2 weeks)
- Impact of providing sensory feedback on proprioception(through study completion, an average of 2 weeks)
- Impact of providing somatosensory feedback on balance(through study completion, an average of 2 weeks)