Chasing Biomarkers in Post-concussion Syndrome

NCT ID: NCT05812742

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-07-31

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.

Conditions

Post Concussive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Enhanced Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Early intervention programme

Intervention Type: BEHAVIORAL

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

Enhanced usual care

Intervention Type: BEHAVIORAL

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

Interventions

Early intervention programme

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

Intervention Type: BEHAVIORAL

Enhanced usual care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sygekassernes Helsefond

OTHER

Sponsor Role: collaborator

Fonden til Lægevidenskabens Fremme

OTHER

Sponsor Role: collaborator

Direktør Emil C. Hertz og Hustru Inger Hertz Fond

UNKNOWN

Sponsor Role: collaborator

Helga Og Peter Kornings Fond

UNKNOWN

Sponsor Role: collaborator

Region MidtJylland Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Preben Eggertsen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Biomarkers in GAIN 1.0

Identifier Type: -

Identifier Source: org_study_id