Clinical trial Recruiting at 1 site Observational Ages 11 to 17

Predicting which children with a concussion are likely to have lasting symptoms

Official title: A Risk Stratification Model for Health and Academic Outcomes in Children With Concussion Based on Novel Symptom Trajectory Typologies

Run by Duke University · NCT05825027 · Data updated 2026-11-12

This project will see if early symptoms, blood markers, and school and social information can predict which children with a recent concussion will still have symptoms over the first year.

Quick facts

Study typeObservational
Ages11 Years to 17 Years
SexAll
Enrollment500 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedMay 23, 2023
Main results expectedFebruary 28, 2028
Study endsFebruary 28, 2028
Registry record updatedJuly 8, 2026
Trial IDNCT05825027 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children who speak English, have a physician-diagnosed concussion that occurred within the past seven days, and have a Glasgow Coma Scale score of 13–15 are ideal candidates.

Probably not a fit

Children with moderate or severe traumatic brain injury, polytrauma, nontraumatic brain injury, pregnant patients, non-English speakers, or those whose injury occurred more than seven days earlier are not eligible and may not benefit from the study findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a longitudinal observational study of children diagnosed with concussion within seven days of injury who will be followed for one year. Researchers will collect symptom reports, measures of fatigue, blood-based inflammatory biomarkers, and academic and social functioning at multiple time points. The goal is to develop a predictive model that identifies children at higher risk for persistent postconcussive symptoms and to inform personalized return-to-learn and return-to-play plans. Findings aim to clarify longer-term physical, psychological, and social impacts of pediatric concussion and help reduce disparities in recovery support.

Why it matters

Potential benefit: If successful, the results could help clinicians and schools identify at-risk children early so they receive targeted care and personalized plans to return to learning and activities.

How similar studies have gone: Prior studies have linked inflammatory biomarkers and symptom severity and have suggested fatigue is relevant, but longitudinal pediatric models that combine biomarkers with symptom, school, and social data are limited, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosed with concussion that occurred within the past 7 days
* Glasgow Coma Scale (GCS) score between 13-15
* English speaking

Exclusion Criteria:

* Diagnosed with moderate or severe traumatic brain injury
* Polytrauma
* Nontraumatic brain injury
* Pregnancy

Where it's running

  • Duke University Health System
    Durham, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.