Clincosm LogoSign in Get a demo

Biomarkers in Concussion

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05943561
Collaborator
(none)
100
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biomarkers in Concussion
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Concussion

    Has an acute concussion
    Non-concussion

    Does not have a concussion

    Outcome Measures

    Primary Outcome Measures

    1. Normalization of NfL levels [12 weeks]

    Secondary Outcome Measures

    1. Resolution of concussion symptoms [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medstar Health Research Institute

    Investigators

    • Principal Investigator: Nicholas Streicher, Medstar Washington Hospital Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas Streicher, Principle Investigator, Medstar Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT05943561
    Other Study ID Numbers:
    • STUDY00006198
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Concussion

    Study Results

    No Results Posted as of Jul 13, 2023