NCT05825027 Risk Stratification in Children With Concussion
| NCT ID | NCT05825027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Concussion, Brain |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-05-23 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.
Eligibility 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
Contact & Investigator
Karin Reuter-Rice, PhD
PRINCIPAL INVESTIGATOR
Duke University School of Nursing
Frequently Asked Questions
Who can join the NCT05825027 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Concussion, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05825027 currently recruiting?
Yes, NCT05825027 is actively recruiting participants. Contact the research team at karin.reuter-rice@duke.edu for enrollment information.
Where is the NCT05825027 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05825027 clinical trial?
NCT05825027 is sponsored by Duke University. The principal investigator is Karin Reuter-Rice, PhD at Duke University School of Nursing. The trial plans to enroll 500 participants.