Establishing Normative Values for the Clinical Use of Cold and Contact Heat-evoked Potentials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evoked potentials variables
研究概览
简要总结
This prospective interventional study aims at recording contact heat evoked potentials (CHEPs) and cold evoked potentials (CEPs) in a healthy population sample in an aim to derive normative values which could be used to evaluate evoked potentials (EPs) of patients.
详细描述
Population sample of 80 healthy volunteers between 26 and 75 years old will be recruited and will be categorized into 5 age subgroups (26-35, 36-45, 46-55, 56-65, 66-75 years old).
Upon arrival, participants will be reminded of the aims and of the content of the experiment. After informed consent (recorded in writing), healthy subjects will be screened with a baseline examination:
- brief neurological examination
- sensory nerve conduction study-related
- quantitative sensory testing
If the baseline examination screening is considered normal, CEPs and CHEPs will be performed. To avoid bias, the side and order of the tests will be randomized.
All thermal stimuli for CEPs and CHEPs will be delivered delivered using a contact thermal stimulator (TCS model II.1, QST.Lab, Strasbourg, France).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 26 and 75 years old having a normal baseline testing.
排除标准
- •Age<26 and >75 years old
- •Known neurological condition.
- •Acute or chronic pain condition.
- •Currently taking drugs that may influence the recording of evoked potentials (analgesics, psychotropic substances, antiepileptics...).
- •History of neurological, or metabolic disorder.
- •Inability to complete study task.
- •History of chemotherapy.
- •Habitual substance abuse(alcoholic beverages intake >21 units/week for males, >14 units/week for females.)
- •Being a volley ball player (due to risk of modified sensibility of the volar forearm skin)
- •Abnormal baseline neurological, SNC or QST testing
结局指标
主要结局
Evoked potentials variables
时间窗: 6 months
Three peaks will be identified in the individual average waveforms of the ERPs elicited by noxious heat and innocuous cold stimulation: a negative-positive complex maximal at the scalp vertex (N2-P2) and an earlier negative wave maximal over the hemisphere contralateral to the stimulated forearm (N1). Latencies and amplitude of the N2 and P2 peaks will be identified at the vertex electrode (Cz) referenced to the mastoids (M1M2). The latency and amplitude of the earlier N1 will be identified at the temporal electrode contralateral to the stimulated arm (Tc) referenced to the frontal midline electrode (Fz). Descriptive statistics will be computed for the evoked potentials variables: N1, N2, P2 latencies as well as N1, N2P2 amplitudes, according to gender, height and age category
次要结局
未报告次要终点