Novel Excitability Protocol to Identify Alteration of Voltage-gated Ion Channels
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Perception threshold for the excitability
研究概览
简要总结
The purpose of subproject 1 is to evaluate the accuracy of a nerve excitability protocol in healthy subjects before testing the protocol in diabetic neuropathy patients. The nerve excitability protocol has been derived by computational modeling to identify abnormalities of three subtypes of ion voltage-gated channels. These three ion channels are all altered in animal models of diabetic neuropathy and, therefore, are likely candidates for generating the altered excitability in diabetic neuropathy patients. The hypothesis for subproject 1 is that due to the unique dynamics of each subtype of voltage-gated ion channels, it is possible to identify abnormal voltage-gated ion channel alterations by altering the shape of the electrical stimulation.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women in the age 18-80 years who speak and understand English.
排除标准
- •Pregnancy or breast feeding
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
- •Skin diseases
- •Past history of conditions possibly leading to neuropathy
- •Inability to cooperate
- •Current use of medications that may affect the study, e.g., analgesics
- •Previous traumatic experience of an electrical accident
- •Consumption of alcohol or painkillers within the last 24 hours
- •Participation in other pain studies throughout the study period
- •Patients with cardiac diseases (e.g., pacemaker).
结局指标
主要结局
Perception threshold for the excitability
时间窗: Approximately 5 minutes to estimate.
The perception threshold will be estimated for a set of electrical stimuli. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
次要结局
- Sensation(Approximately 5 minutes to estimate.)
研究者
Jenny Tigerholm
Assistant Professor
Aalborg University