Investigating Composite Biomarkers for Pain Catastrophizing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Oscillations of the main electroencephalogram (EEG) frequency
研究概览
简要总结
Pain is a complex, multidimensional, and subjective experience; and although, investigators use a single word "pain", to describe our perception, multiple mechanisms contribute to the generation and maintenance of pain. To help diagnosing and improving pain management, there is a need for developing tools. These tools may include measurements of substances, or biomarkers, in the blood; e.g. small molecules called microRNA and proteins. In these experiments, the investigators would like to investigate how the psychological response to stress and pain alters the impulses in the brain and the content of microRNA and proteins in the blood. The future aim is to identify patients in high risk of developing and maintaining chronic pain and to be able to treat chronic pain efficiently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Speak and understand English
排除标准
- •Acute and chronic pain
- •Pregnancy or breastfeeding
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
- •Focal and generalized seizure
- •Surgery or any other therapy for epilepsy
- •Present or previous AEDs (anti-epileptic drugs) administration
- •Present or previous use of epileptic devices (<1 year prior the enrolment)
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
研究组 & 干预措施
hypertonic saline
干预措施: hypertonic saline (Drug)
isotonic saline
干预措施: isotonic saline (Drug)
结局指标
主要结局
Oscillations of the main electroencephalogram (EEG) frequency
时间窗: 10 minutes of recording after isotonic/hypertonic injection
Electroencephalographic (EEG) recording will be performed placing a 64-electrodes cap over the scalp according to the 10-20 international system. Oscillations of the main EEG frequency bands (delta, alpha, beta, gamma) from the frontal and parietal lobes will be detected and correlated to the individual pain rate as well as the dimensions of the psychological questionnaires.
Perturbation of the electroencephalogram (EEG) rhythms
时间窗: 10 minutes of recording after isotonic/hypertonic injection
Electroencephalographic (EEG) recording will be performed placing a 64-electrodes cap over the scalp according to the 10-20 international system. Perturbation of the above-mentioned EEG rhythms will be measured in response to the hypertonic/isotonic saline injection and compared to a resting state baseline recording.
Collection of blood samples
时间窗: time 4 (72 hours)
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected into SST™ II Advance Serum Separation Tubes containing anticoagulant EDTA.
Proteome analysis
时间窗: time 4 (72 hours)
From the blood samples previously collected, the protein concentration will be determined. Protein sequencing will be done using mass spectrometers.
MicroRNAs (miRNAs) expression analysis
时间窗: time 4 (72 hours)
From the blood samples previously collected, miRNA will be isolated for a subsequent miRNA library preparation. Subsequently, extracted miRNA will be reversely transcribed, and cDNA will be used for total miRNAs sequencing.
Plasma cortisol levels measurements
时间窗: time 4 (72 hours)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma Interleukin-6 (IL-6) levels measurements
时间窗: time 0 (baseline)
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Plasma Interleukin-6 levels measurements
时间窗: time 4 (72 hours)
From the blood samples previously collected, plasma levels of IL-6 will be evaluated through enzyme-linked immunosorbent assay (ELISA).
Metabolome analysis
时间窗: time 4 (72 hours)
From the blood samples previously collected. Metabolites will be investigated and identified by a 4D feature finding using Metaboscape.
Plasma cortisol levels measurement
时间窗: time 0 (baseline)
From the blood samples previously collected, plasma levels of cortisol will be evaluated through enzyme-linked immunosorbent assay (ELISA).
次要结局
- Measuring Pain using VAS(20 minutes)
研究者
Laura Petrini
Associate Professor
Aalborg University