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临床试验/NCT05192577
NCT05192577已完成不适用

Nerve Excitability Testing Protocol for Cold-sensing Fibers

Aalborg University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年11月24日最近更新:
适应症

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
2
主要终点
Warm pain threshold with conditioning electrical stimuli

研究概览

简要总结

This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).

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

入选标准

  • Healthy men and women
  • 18-80 years
  • 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

Warm pain threshold with conditioning electrical stimuli

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a warm painful sensation. Simultaneous will electrical stimulation be applied.

Cold pain threshold with conditioning electrical stimuli

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a cold painful sensation. Simultaneous will electrical stimulation be applied.

The sensation of pulse 1

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The investigator will ask the participant to rate the sensation by a questionnaire. The scale will be 0-10, where 0 indicates no sensation and 10 is the worst imaginable sensation.

Cold detection threshold with conditioning electrical stimuli

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.

Cold pain threshold

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.

Warm pain threshold

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.

Cold detection threshold

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.

Perception threshold

时间窗: During session 1. The estimation of the outcome measurement take approximately 15 minutes.

The Perception threshold for the cutaneous electrical stimulation will be estimated for two different pulse shapes of the electrical stimulus. The perception threshold is defined as the electrical current needed for the participant to perceive the stimulus. The perception threshold will be estimated by the method of limits.

Warm detection threshold

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.

Warm detection threshold with conditioning electrical stimuli

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.

The sensation of pulse 2

时间窗: During session 1. The estimation of the outcome measurement take approximately 3 minutes.

The investigater will ask the participant to rate the sensation by a questionnaire. The scale will be from 0-10 where 0 indication no sensation and 10 the worst imaginable sensation.

次要结局

未报告次要终点

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Tigerholm

Assistant Professor

Aalborg University

研究点 (2)

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