Investigating the Neurophysiology of Itch
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Measuring pain by computerized Visual Analog Scale Scoring
研究概览
简要总结
This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.
详细描述
Two areas (4x4 cm, one on each forearm), will be selected. Initially, superficial blood perfusion will be measured in each area, followed by pruritogens application. During the 10 minutes of the application of the pruritogens, itch will be continuously monitored using a VAS scale. After the pruritogens application, assessment of the superficial blood perfusion (SBP), mechanical sensitivity, and thermal sensitivity will be conducted. The session will be identical to the first session, but pre-heat conditioning will be applied prior to pruritogens application.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- •Previous or current history of neurological (e.g., neuropathy), immunological (e.g., asthma, immune deficiencies, arthritis), musculoskeletal (e.g., muscular pain in the upper extremities), cardiac disorder (e.g., stroke), or psychiatric diagnoses (e.g., depression, bipolar disorders, acute and chronic psychosis) that may affect the results
- •Current use of medications that may affect the trial, such as antihistamines, antipsychotics, painkillers, and systemic or topical steroids
- •Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
- •Moles, scars, or tattoos in the area to be treated or tested (forearm/hand).
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain
- •Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" (subprojects 2-4)
- •Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.) (subprojects 2-4)
- •Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos (subprojects 2-4)
- •Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application sites (subprojects 2, 3, and 4)
- •Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- •The subject is assessed as unable to engage in the necessary cooperation required by the study
研究组 & 干预措施
Active group
Heath will be applied prior pruritogens application
干预措施: Cowhage (Mucuna Pruriens) (Other)
Active group
Heath will be applied prior pruritogens application
干预措施: Histamine (Other)
Active group
Heath will be applied prior pruritogens application
干预措施: Heat (Other)
结局指标
主要结局
Measuring pain by computerized Visual Analog Scale Scoring
时间窗: Day 1
We will ask the subjects to rate the sensation of pain on a 100
Measuring Itch by computerized Visual Analog Scale Scoring
时间窗: Day 1
We will ask the subjects to rate the sensation of itch on a 100
Measuring pain by computerized Visual Analog Scale Scoring
时间窗: Day 2
We will ask the subjects to rate the sensation of pain on a 100
Measuring Itch by computerized Visual Analog Scale Scoring
时间窗: Day 2
We will ask the subjects to rate the sensation of itch on a 100
次要结局
- Superficial blood perfusion(Day 1)
- Superficial blood perfusion(Day 2)
- Alloknesis(Day 1)
- Alloknesis(Day 2)
- Mechanically evoked itch (MEI)(Day 1)
- Mechanically evoked itch (MEI)(Day 2)
- Mechanical Pain Thresholds (MPT)(Day 1)
- Mechanical Pain Thresholds (MPT)(Day 2)
- Mechanical Pain Sensitivity (MPS)(Day 1)
- Mechanical Pain Sensitivity (MPS)(Day 2)
- Cold Detection Thresholds (CDT)(Day 1)
- Cold Detection Thresholds (CDT)(Day 2)
- Warm Detection Thresholds (WDT)(Day 1)
- Warm Detection Thresholds (WDT)(Day 2)
- Cold Pain Thresholds (CPT)(Day 1)
- Cold Pain Thresholds (CPT)(Day 2)
- Heat Pain Thresholds (HPT)(Day 1)
- Heat Pain Thresholds (HPT)(Day 2)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 1)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 2)
研究者
Silvia Lo Vecchio
Associate Professor
Aalborg University