Biomarkers in Concussion

Not yet recruiting

• Conditions: Concussion, Severe; Concussion, Mild; Concussion, Intermediate

• Registration Number: NCT05943561
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Study Start: 2023-09
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study.

Exclusion criteria:

Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Normalization of NfL levels	12 weeks

Secondary Outcome Measures

Name	Time	Method
Resolution of concussion symptoms	12 weeks