Clinical trial NCT05812742: Chasing Biomarkers in Post-concussion Syndrome
Official title: Neurofilament Light Chain, Inflammatory Markers, Calcitonin Gene-related Peptide, and Kynurenine Metabolites in Patients With Severe Post-concussive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Concussive Symptoms
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Sygekassernes Helsefond
name: Fonden til Lægevidenskabens Fremme
name: Direktør Emil C. Hertz og Hustru Inger Hertz Fond
name: Helga Og Peter Kornings Fond
name: Region MidtJylland Denmark
First posted: 2023-04-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Patients with severe post-concussive symptoms:

Inclusion Criteria:

1. Concussion caused by a head trauma based on the diagnostic criteria recommended by the World Health Organization (WHO) Task Force
2. Age between 18 and 30 years
3. Able to understand, speak and read Danish.
4. A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).

Exclusion Criteria:

1. Objective neurological findings indicating neurological disease or brain damage.
2. Previous concussion leading to persistent post-concussional symptoms within the last two years.
3. Severe misuse of alcohol, prescription drugs and / or illegal drugs.
4. Severe psychiatric, neurological,or other medical disease that would impede participation in the intervention
5. 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:

1. Age between 18-30 years
2. 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.

Primary outcomes:
measure: Neurofilament light chain at baseline (primary outcome)
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: 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.
measure: Self-reported post-concussion symptoms score (primary outcome)
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
measure: Calcitonin-gene related peptide at baseline (CGRP)
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: 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.
Secondary outcomes:
measure: Quinolinic acid at baseline
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: Quinolinic acid at follow-up
timeFrame: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
measure: Neuroprotective index at baseline
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: Neuroprotective index at follow-up
timeFrame: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
measure: Inflammatory markers at baseline
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: Inflammatory markers at baseline
timeFrame: The baseline blood sample was taken up to 7 months after the concussion (4 months median).
measure: Inflammatory markers at follow-up
timeFrame: The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.
Other outcomes:
Locations:
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic and Research Unit for Molecular Medicine (Aarhus University)
name: Peter Preben Eggertsen, MD
role: PRINCIPAL_INVESTIGATOR
References: