Neurofilament Light Chain, Inflammatory Markers, Calcitonin Gene-related Peptide, and Kynurenine Metabolites in Patients With Severe Post-concussive Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Concussive Symptoms
- Sponsor
- University of Aarhus
- Enrollment
- 86
- Primary Endpoint
- Neurofilament light chain at baseline (primary outcome)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Neurofilament light chain at baseline (primary outcome)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
- 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 baseline(The baseline blood sample was taken up to 7 months after the concussion (4 months median).)
- 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.)