Neurofilament Light Chain, Inflammatory Markers, Calcitonin Gene-related Peptide, and Kynurenine Metabolites in Patients With Severe Post-concussive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Neurofilament light chain at baseline (primary outcome)
研究概览
简要总结
The goal of this study was to investigate the biomarkers, neurofilament light chain, inflammatory markers, calcitonin-gene-related peptide, and metabolites from the kynurenine pathway in patients with severe post-concussive symptoms. The main question it aimed to answer was:
- Are the biomarker concentrations significantly changed in patients with severe post-concussive symptoms compared to healthy individuals?
- Do the biomarker concentrations change at follow-up?
Participants were recruited from a recently published randomized controlled trial (Clinicaltrials.gov no. NCT02337101 / PMID: 31891145 ). The biomarker concentrations were compared to a healthy control group recruited from the Blood Bank at Aarhus University Hospital in 2022.
详细描述
In the previously published RCT-study (PMID: 31891145), 86 participants with severe post-concussive symptoms provided blood samples at baseline (4 months after the concussion). Severe post-concussive symptoms were defined as having a Rivermead Post Concussion Questionnaire >20.
Around 7 months later, a follow-up blood sample was obtained from 54 participants.
These blood samples were used to investigate blood biomarkers for the condition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Concussion caused by a head trauma based on the diagnostic criteria recommended by the World Health Organization (WHO) Task Force
- •Age between 18 and 30 years
- •Able to understand, speak and read Danish.
- •A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).
排除标准
- •Objective neurological findings indicating neurological disease or brain damage.
- •Previous concussion leading to persistent post-concussional symptoms within the last two years.
- •Severe misuse of alcohol, prescription drugs and / or illegal drugs.
- •Severe psychiatric, neurological,or other medical disease that would impede participation in the intervention
- •Inability to speak and read Danish
- •Healthy control group (recruited from December 2021 - March 2022):
- •Individuals from the Blood Bank at Aarhus University Hospital in Denmark.
- •Inclusion criteria were:
- •Age between 18-30 years
- •Equal distribution between the genders (60 men and 60 women). This number was based on a power analysis using published data from neurofilament light chain.
结局指标
主要结局
Neurofilament light chain at baseline (primary outcome)
时间窗: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
The investigators hypothesized: The concentration of neurofilament light chain (ng/L) is significantly increased at baseline in patients compared to the healthy control group.
Neurofilament light chain at follow-up (primary outcome)
时间窗: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
The investigators hypothesized: 1)The neurofilament light chain concentration (ng/L) normalizes (decreases) at follow-up compared to the baseline concentration in patients.
Self-reported post-concussion symptoms score (primary outcome)
时间窗: The baseline symptom score (RPQ) was obtained from the patients up to 7 months after the concussion (4 months median), and the follow-up score was obtained up to 16 months (10.5 median) after the concussion
The symptom score was measured at both baseline and follow-up using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a self-reported questionnaire. The Rivermead Post-Concussion Symptoms Questionnaire contains 16 items which is rated from 0 (not experienced) to 4 (a severe problem). The total score thus ranges on a scale between 0-64.
Calcitonin-gene related peptide at follow-up (CGRP)
时间窗: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
The investigators hypothesized: The CGRP concentrations (pg/mL) will normalize (increase) at follow-up compared to baseline.
Calcitonin-gene related peptide at baseline (CGRP)
时间窗: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
The investigators hypothesized: The concentration of calcitonin gene-related peptide (pg/mL) is decreased compared to the healthy control group at baseline
次要结局
- Neuroprotective index at baseline(The baseline blood sample was taken up to 7 months after the concussion (4 months median).)
- Quinolinic acid at baseline(The baseline blood sample was taken up to 7 months after the concussion (4 months median).)
- Quinolinic acid at follow-up(The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.)
- Neuroprotective index at follow-up(The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.)
- Inflammatory markers at follow-up(The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.)
- Inflammatory markers at baseline(The baseline blood sample was taken up to 7 months after the concussion (4 months median).)