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| Name | Class |
|---|---|
| Sygekassernes Helsefond | OTHER |
| Fonden til Lægevidenskabens Fremme | OTHER |
| Direktør Emil C. Hertz og Hustru Inger Hertz Fond | UNKNOWN |
| Helga Og Peter Kornings Fond |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | Active Comparator | For more details on the intervention, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145). Enhanced Usual Care (EUC) All patients had a brief clinical psychiatric and neurological assessment in order to determine eligibility, and they were provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication. |
|
| Enhanced Usual Care + Early intervention programme | Experimental | For more details on the intervention, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145). Behavioral: EUC + Early intervention programme All patients had a brief clinical psychiatric and neurological assessment in order to determine eligibility, and were provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication. The early intervention programme was interdisciplinary and was provided by an occupational therapist and a physiotherapist under supervision of a neuropsychologist. It was based on psychoeducation and principles from Cognitive Behavioral Therapy and Graded Exercise Therapy and targeted to patients' individual goals. Patients received 8 weekly treatment sessions (3 group based and 5 individual sessions). The intervention started approximately 4 months after the concussion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early intervention programme | Behavioral | For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurofilament light chain at baseline (primary outcome) | The investigators hypothesized: The concentration of neurofilament light chain (ng/L) is significantly increased at baseline in patients compared to the healthy control group. | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Neurofilament light chain at follow-up (primary outcome) | The investigators hypothesized: 1)The neurofilament light chain concentration (ng/L) normalizes (decreases) at follow-up compared to the baseline concentration in patients. | The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample. |
| Self-reported post-concussion symptoms score (primary outcome) | 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. | 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 |
| Calcitonin-gene related peptide at baseline (CGRP) | The investigators hypothesized: The concentration of calcitonin gene-related peptide (pg/mL) is decreased compared to the healthy control group at baseline | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Calcitonin-gene related peptide at follow-up (CGRP) | The investigators hypothesized: The CGRP concentrations (pg/mL) will normalize (increase) at follow-up compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Quinolinic acid at baseline | The investigators hypothesized that: The concentration of the neurotoxic metabolite, quinolinic acid (measured in nM), is increased in patients compared to healthy controls | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Quinolinic acid at follow-up |
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Patients with severe post-concussive symptoms:
Inclusion Criteria:
Exclusion Criteria:
Healthy control group (recruited from December 2021 - March 2022):
- Individuals from the Blood Bank at Aarhus University Hospital in Denmark.
Inclusion criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Preben Eggertsen, MD | Hammel Neurorehabilitation Centre and University Research Clinic and Research Unit for Molecular Medicine (Aarhus University) | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2023 | Feb 28, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| UNKNOWN |
| Region MidtJylland Denmark | OTHER |
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| Enhanced usual care | Behavioral | For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145). |
|
| 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 quinolinic acid concentration (nM) normalizes (decreases) at follow-up compared to the baseline concentration. |
| The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample. |
| Neuroprotective index at baseline | The investigators hypothesized: The ratio between the neuroprotective metabolite kynurenic acid (KYNA) and the neurotoxic metabolite quinolinic acid (KynA/QUIN) is lower than the ratio in healthy individuals at baseline. A higher ratio means a better outcome. | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Neuroprotective index at follow-up | The investigators hypothesized: The ratio between the neuroprotective metabolite kynurenic acid (KYNA) and the neurotoxic metabolite quinolinic acid (QUIN) normalizes (increases) at follow-up compared to baseline. A higher ratio thus means a better outcome. | 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 investigators hypothesized that: Tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6) (both pg/mL) are increased in patients compared to healthy controls. | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Inflammatory markers at baseline | The investigators hypothesized: Basic fibroblast growth factor (Basic FGF), Eotaxin, interferon gamma (IFN-y), interleukin 1 beta (IL-1B), interleukin 8 (IL-8), interleukin 9 (IL-9), interleukin 17 (IL17), Interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), and Macrophage Inflammatory Protein beta (MIP-1b) (all pg/mL) are significantly increased in patients compared to controls (hypothesis is based on a recent study (PMID: 32326805) | The baseline blood sample was taken up to 7 months after the concussion (4 months median). |
| Inflammatory markers at follow-up | TNF-α and IL-6 (both pg/mL) decreases at follow-up compared to the baseline value in patients. | The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample. |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |