Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion

NCT05588115 | Recruiting

• 1 other identifier: REB22-1015
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to test if a biosensor can accurately measure a blood biomarker in adult patients presenting to the emergency department with concussion. The main questions it aims to answer are:

• Does the biosensor measure the blood biomarker of interest with the same accuracy as the current gold-standard assay technique?
• Do relationships exist between blood biomarker measurements from the biosensor and any psychological or physical symptoms of concussion? Participants will be asked to provide blood samples at initial visit and 2-, 6-, and 12-weeks after injury while completing questionnaires at each visit, along with a brief (2 min) daily symptom inventory. Researchers will compare the concussion group to a muscle/skeletal injury group to see if measurements from the biosensor are exclusive to concussion.

Conditions

Concussion, Mild

Keywords

blood biomarkers; GFAP; biosensor; concussion

Outcome Measures

Primary Outcomes (8)

• Blood serum concentrations of GFAP at initial visit

  Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  Up to 1 week following injury

• Blood serum concentrations of GFAP at 2 week follow up

  Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  2-3 weeks following injury

• Blood serum concentrations of GFAP at 6 week follow up

  Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  6-7 weeks following injury

• Blood serum concentrations of GFAP at 12 week follow up

  Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  12-13 weeks following injury

• Blood plasma concentrations of GFAP at initial visit

  Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  Up to 1 week following injury

• Blood plasma concentrations of GFAP at 2 week follow up

  Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  2-3 weeks following injury

• Blood plasma concentrations of GFAP at 6 week follow up

  Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  6-7 weeks following injury

• Blood plasma concentrations of GFAP at 12 week follow up

  Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.

  12-13 weeks following injury

Secondary Outcomes (36)

• Glasgow Outcome Scale Extended (GOSE)

  Up to 1 week following injury

• Glasgow Outcome Scale Extended (GOSE)

  2-3 weeks following injury

• Glasgow Outcome Scale Extended (GOSE)

  6-7 weeks following injury

• Glasgow Outcome Scale Extended (GOSE)

  12-13 weeks following injury

• Glasgow Outcome Scale Extended (GOSE)

  24-25 weeks following injury

Study Arms (2)

Concussion

Patients presenting to the ED who are diagnosed with concussion according to the ICD-10 criteria and absent of comorbidities.

MSK

Patients presenting to the ED who are diagnosed with a muscle or skeletal injury (MSK; soft tissue damage or inflammation, fractured bone, etc.) and absent of comorbidities.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For the exposure of interest group, adult patients (ages 18 to 65) with an uncomplicated concussion diagnosis at Foothills Medical Centre Emergency Department in Calgary Alberta will be approached to participate in this study regardless of race, ethnicity, or gender. For the control group, adult patients (ages 18 to 65) with a musculoskeletal (MSK) injury (fractured bone, connective tissue damage, etc.) at Foothills Medical Centre Emergency Department in Calgary Alberta will be approached to participate in this study regardless of race, ethnicity, or gender.

You may qualify if:

• diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities
• between the ages of 18-65 years old.
• diagnosed with any form of musculoskeletal injury in absence of comorbidities
• between the ages of 18-65 years old

You may not qualify if:

• complicated mild TBI (positive neuroimaging findings)
• current or history of moderate or severe traumatic brain injury
• history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.)
• greater than 7 days from injury at initial visit

Sponsors & Collaborators

• University of Calgary: lead
• Foothills Medical Centre: collaborator

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Related Publications (13)

• Cassidy JD, Carroll LJ, Peloso PM, Borg J, von Holst H, Holm L, Kraus J, Coronado VG; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):28-60. doi: 10.1080/16501960410023732.

  PMID: 15083870 BACKGROUND

• Najem D, Rennie K, Ribecco-Lutkiewicz M, Ly D, Haukenfrers J, Liu Q, Nzau M, Fraser DD, Bani-Yaghoub M. Traumatic brain injury: classification, models, and markers. Biochem Cell Biol. 2018 Aug;96(4):391-406. doi: 10.1139/bcb-2016-0160. Epub 2018 Jan 25.

  PMID: 29370536 BACKGROUND

• Gordon KE, Kuhle S. Canadians Reporting Sport-Related Concussions: Increasing and Now Stabilizing. Clin J Sport Med. 2022 May 1;32(3):313-317. doi: 10.1097/JSM.0000000000000888. Epub 2020 Sep 17.

  PMID: 32956100 BACKGROUND

• Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.

  PMID: 4136544 BACKGROUND

• McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available.

  PMID: 28446457 BACKGROUND

• McMahon P, Hricik A, Yue JK, Puccio AM, Inoue T, Lingsma HF, Beers SR, Gordon WA, Valadka AB, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Symptomatology and functional outcome in mild traumatic brain injury: results from the prospective TRACK-TBI study. J Neurotrauma. 2014 Jan 1;31(1):26-33. doi: 10.1089/neu.2013.2984. Epub 2013 Oct 31.

  PMID: 23952719 BACKGROUND

• Olesen J, Leonardi M. The burden of brain diseases in Europe. Eur J Neurol. 2003 Sep;10(5):471-7. doi: 10.1046/j.1468-1331.2003.00682.x.

  PMID: 12940825 BACKGROUND

• Morrison L, Taylor R, Mercuri M, Thompson J. Examining Canada's return visits to the emergency department after a concussion. CJEM. 2019 Nov;21(6):784-788. doi: 10.1017/cem.2019.22.

  PMID: 30947758 BACKGROUND

• McCrea M, Meier T, Huber D, Ptito A, Bigler E, Debert CT, Manley G, Menon D, Chen JK, Wall R, Schneider KJ, McAllister T. Role of advanced neuroimaging, fluid biomarkers and genetic testing in the assessment of sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):919-929. doi: 10.1136/bjsports-2016-097447. Epub 2017 Apr 28.

  PMID: 28455364 BACKGROUND

• Olsson B, Lautner R, Andreasson U, Ohrfelt A, Portelius E, Bjerke M, Holtta M, Rosen C, Olsson C, Strobel G, Wu E, Dakin K, Petzold M, Blennow K, Zetterberg H. CSF and blood biomarkers for the diagnosis of Alzheimer's disease: a systematic review and meta-analysis. Lancet Neurol. 2016 Jun;15(7):673-684. doi: 10.1016/S1474-4422(16)00070-3. Epub 2016 Apr 8.

  PMID: 27068280 BACKGROUND

• Zetterberg H, Blennow K. Fluid biomarkers for mild traumatic brain injury and related conditions. Nat Rev Neurol. 2016 Oct;12(10):563-74. doi: 10.1038/nrneurol.2016.127. Epub 2016 Sep 16.

  PMID: 27632903 BACKGROUND

• Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.

  PMID: 30054151 BACKGROUND

• Kuhle J, Barro C, Andreasson U, Derfuss T, Lindberg R, Sandelius A, Liman V, Norgren N, Blennow K, Zetterberg H. Comparison of three analytical platforms for quantification of the neurofilament light chain in blood samples: ELISA, electrochemiluminescence immunoassay and Simoa. Clin Chem Lab Med. 2016 Oct 1;54(10):1655-61. doi: 10.1515/cclm-2015-1195.

  PMID: 27071153 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, and serum.

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Chantel T Debert, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantel T Debert, MD, MSc

CONTACT

4039444500; cdebert@ucalgary.ca

Linden C Penner, MSc

CONTACT

7802631373; linden.penner@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 20, 2022
• Study Start: December 1, 2022
• Primary Completion: April 30, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)