Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in PTT-value
研究概览
简要总结
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.
The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).
详细描述
Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room.
Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms.
In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%).
The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant and investigator/project involved personal is blinded to which cream is applied.
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
- •Men and Women age > 18 years
- •Understand and speak Danish
- •No medication besides contraceptives
排除标准
- •Pregnancy or lactating women
- •Drug addiction (use of cannabis, opioids, or other drugs)
- •Use of pain killers, alcohol, or nicotine within the last 24 hours before study start
- •Any other medical treatment (e.g., antidepressants, anticonvulsants)
- •History of peripheral or chronic pain conditions / neuropathy
- •Skin diseases
- •Scars and/or tattoos at the volar site of the forearm
- •Previous traumatic experience of an electrical accident
- •Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
- •Participation in any other research projects/studies 7 days before study start
- •Known allergy/intolerance to lidocaine/phenytoin/mepyramine
- •Lack of ability to cooperate
研究组 & 干预措施
Pharmacological modulation with lidocaine 5%
Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated
干预措施: Topical lidocaine 5% (Drug)
Pharmacological modulation with Phenytoin 10%
Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated
干预措施: Topical Phenytoin 10% (Drug)
Pharmacological modulation with Mepyramine 2%
Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated
干预措施: Topical Mepyramine 2% (Drug)
Control
Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated
干预措施: Topical Placebo (Other)
结局指标
主要结局
Change in PTT-value
时间窗: 1 hour after application of cream
Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.
次要结局
未报告次要终点
研究者
Carsten Dahl Mørch
M.Sc., Ph.D., Associate Professor
Aalborg University