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NCT05943561 Clinical Trial

Biomarkers in Concussion

Concussion, Mild Clinical Trial

Official title:
Biomarkers in Concussion

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05943561
Other study ID # STUDY00006198
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date June 2024

Study information
Verified date August 2023
Source Medstar Health Research Institute
Contact Emma Merrill
Phone 2028776607
Email emma.merrill@medstar.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medstar Health Research Institute

Outcome
Type Measure Description Time frame Safety issue
Primary Normalization of NfL levels 12 weeks
Secondary Resolution of concussion symptoms 12 weeks
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