Risk Stratification in Children With Concussion

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05825027
Status
Recruiting
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Conditions

  • Concussion, Brain
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
11 Years - 17 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 23, 2023
Status verified
Jul 2025
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Change in concussion symptom burden and severity as measured by the Post Concussion Symptom Scale (PCSS) [ Time Frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710
Clinical Research Coordinator

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Duke University Health System· Durham, NC

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