Chasing Biomarkers in Post-concussion Syndrome (NCT05812742) | Clinical Trial Compass
CompletedNot Applicable
Chasing Biomarkers in Post-concussion Syndrome
86 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurofilament light chain at baseline (primary outcome)
Timeframe: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
2
Neurofilament light chain at follow-up (primary outcome)
Timeframe: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
Timeframe: 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
4
Calcitonin-gene related peptide at baseline (CGRP)
Timeframe: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
5
Calcitonin-gene related peptide at follow-up (CGRP)
Timeframe: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
. 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
. 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.