Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05825027

Conditions

Concussion, Brain

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Concussion, Brain

Mild Traumatic Brain Injury

Study ID

NCT05825027

Start date

May 23, 2023

Status verified date

Jul, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

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 ]
  • Change in post concussion fatigue burden and severity as measured by the PROMIS Pediatric Item Bank v2.0 - Fatigue [ 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 ]
  • Change in degree of involvement with one's peers in usual social roles, activities and responsibilities as measured by the Neuro-QoL Item Bank v1.0 - Pediatric Social Relations - Interaction with Peers [ 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 ]
  • Change in perceived difficulties in everyday cognitive abilities such as memory, attention, concentration, processing speed and organization skill as measured by the Neuro-QoL Item Bank v2.0 - Pediatric Cognitive Function [ 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 ]
  • Change in academic needs of a student following concussion as measured by the Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3) [ 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 ]
  • Salivary Interferon Gamma [ 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 ]
  • Salivary Interleukin-1 Beta [ 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 ]
  • Salivary Interleukin-6 [ 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 ]
  • Salivary Interleukin-8 [ 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 ]
  • Salivary Interleukin-10 [ 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 ]
  • Salivary TNF-Alpha [ 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 ]
  • Pubertal status [ 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 ]
  • Presence of genetic variants in genes that code for inflammatory cytokines [ Time Frame: Within 7 days of injury ]

Central Contacts and Locations

Central contacts

Karin Reuter-Rice, PhD

919-681-7647karin.reuter-rice@duke.edu

Amanda Fitterer, MPH

amanda.fitterer@duke.edu

Locations

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Duke University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-08.