Chasing Biomarkers in Post-concussion Syndrome

NCT05812742 | Completed

• 1 other identifier: Biomarkers in GAIN 1.0
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Concussive Symptoms

Outcome Measures

Primary Outcomes (5)

• 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.

  The follow-up blood sample was taken up to 12 months after baseline (7 months median) after the baseline blood sample.

Secondary Outcomes (7)

• 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 baseline

  The baseline blood sample was taken up to 7 months after the concussion (4 months median).

• 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).

Study Arms (2)

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.

Behavioral: Enhanced usual care

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.

Behavioral: Early intervention programme; Behavioral: Enhanced usual care

Interventions

Early intervention programme BEHAVIORAL

For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).

Enhanced Usual Care + Early intervention programme

Enhanced usual care BEHAVIORAL

For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).

Enhanced Usual Care; Enhanced Usual Care + Early intervention programme

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Sygekassernes Helsefond: collaborator
• Fonden til Lægevidenskabens Fremme: collaborator
• Direktør Emil C. Hertz og Hustru Inger Hertz Fond: collaborator
• Helga Og Peter Kornings Fond: collaborator
• Region MidtJylland Denmark: collaborator

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Peter Preben Eggertsen, MD

  Hammel Neurorehabilitation Centre and University Research Clinic and Research Unit for Molecular Medicine (Aarhus University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 14, 2023
• Study Start: March 1, 2015
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 16, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share