Biomarkers in Concussion

August 31, 2023 updated by: Nicholas Streicher, Medstar Health Research Institute
This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Athletes with or without concussion.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Concussion
Has an acute concussion
Non-concussion
Does not have a concussion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normalization of NfL levels
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Resolution of concussion symptoms
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Nicholas Streicher, MedStar Washington Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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