NCT02992327

Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

The overall research aim of this pilot study is to determine if the structural brain protein calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to accurately identify patients who will have more severe symptoms and reduced neurocognitive functioning after sustaining a concussion. Concussion is also referred to as mild traumatic brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout this application.

Detailed description

The novel aspect of the proposed study relates to the fact that the STNF protein is the first evidence that a biomarker in human blood can help clinicians determine a specific patient's clinical outcome from a concussion. This in turn will help clinicians and concussion specialists with designing treatment protocols very early after the initial injury that could have significant impacts on the health of the patient. This study has several important benefits to the scientific community. Concussion treatment today is uncertain. Some patients are back to baseline one or two days post injury whereas other patients are experiencing debilitating symptoms for months after the injury. Until the patient begins to report symptoms, the course of treatment cannot be determined. Other biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to show promise for patient stratification and earlier intervention and treatment for the subset of cases at high risk of suffering brain damage and persisting dysfunction after concussion. Currently, no prognostic method exists for identifying at an early and potentially treatable stage the small subset of concussion sufferers at risk of diffuse axonal injury and persisting brain functional impairment.

Conditions

• Concussion, Mild
• Neurocognitive Dysfunction

Timeline

• Start date: 2015-08-30
• Primary completion: 2018-08-06
• Completion: 2018-08-06
• First posted: 2016-12-14
• Last updated: 2018-09-07

Locations

1 site across 1 country: United States