Predicting which children with a concussion are likely to have lasting symptoms
A Risk Stratification Model for Health and Academic Outcomes in Children With Concussion Based on Novel Symptom Trajectory Typologies
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05825027 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- Duke University Health System — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Karin Reuter-Rice, PhD — Duke University School of Nursing
- Study coordinator: Karin Reuter-Rice, PhD
- Email: karin.reuter-rice@duke.edu
- Phone: 919-681-7647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.