NCT05812742

Chasing Biomarkers in Post-concussion Syndrome

Neurofilament Light Chain, Inflammatory Markers, Calcitonin Gene-related Peptide, and Kynurenine Metabolites in Patients With Severe Post-concussive Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Concussive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Early intervention programme	For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).
BEHAVIORAL	Enhanced usual care	For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).

Timeline

• Start date: 2015-03-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2023-04-14
• Last updated: 2024-04-16