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NCT Number: NCT05825027

Risk Stratification in Children With Concussion

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.

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mild Traumatic Brain Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

About this study

Concussions occur at an alarming rate among U.S. schoolchildren, with one in five children experiencing a concussion by age 16. The number of children visiting emergency departments for concussions annually has increased by 50% over the past decade, with an estimated cost to the healthcare system of $1 billion/year. Compared to adults, children experience longer and more severe postconcussive symptoms (PCS). Severity and duration of PCS, however, vary considerably among children, complicating clinical care and return to learn and play. Persistent PCS including physical, emotional, and cognitive symptoms, result in increased school absenteeism, social isolation, and psychological distress. Early PCS diagnosis and access to evidence-based return-to-health and -school interventions are strongly linked to positive health and academic outcomes. Yet models to identify children at high risk for persistent PCS are lacking. PCS have been linked to inflammatory processes occurring within the injured brain. Preliminary evidence suggests that fatigue, another symptom likely contributing to poor outcomes, is also a biological byproduct of pediatric concussions. Importantly, even though 73% of children report continuous fatigue after concussion, this symptom is rarely studied along with other PCS. Prior research has focused on the relationship between inflammatory biomarkers and PCS severity but has not examined this relationship longitudinally. Acute symptom severity alone, however, is a poor prognostic of clinical outcomes in concussed children. Symptom severity immediately postinjury does not explain why at least 25% of children still experience PCS after 1 year or why even children who may appear asymptomatic still report academic and social challenges months after concussion. To identify which children are at high risk for persistent PCS and poor health, academic, and social outcomes, research tracking PCS trajectories and describing school-based impacts across the entire first year postinjury is critically needed. This proposal will 1) define novel PCS trajectory typologies in a racially/ethnically diverse population of 500 children with concussion (11-17 years, near equal distribution by sex), 2) identify associations between these typologies and patterns of inflammatory biomarkers, 3) develop a risk stratification model to identify children at risk for persistent PCS; and 4) gain unique insights and describe PCS impact, including fatigue, on longer-term academic and social outcomes. We will be the first to use NIH's symptom science model and patient-reported outcomes to explore the patterns of fatigue and other physical, cognitive, psychological, emotional and academic responses to concussion in children over a full year. Our model will enable clinicians and educators to identify children most at risk for poor long-term health, social, and academic outcomes after concussion. This work is critical to meeting our long-term goal of developing personalized concussion symptom management strategies to improve outcomes and reduce disparities in the health and quality of life of children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    The PCSS consists of 22 questions that relate to post-concussive symptoms. Survey-takers are asked to rate each symptom according to a 7-point Likert scale ranging from 0-6. Higher scores indicate a higher severity of post-concussive symptoms. The greatest possible score is 132 and the lowest possible score is 0.

  2. 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

    The PROMIS Pediatric Fatigue item bank consists of 25 self-report items which measure fatigue symptoms in children aged 8-17 years. Items are ranked on a 5-point likert scale ranging from 1 (Never) to 5 (Almost Always). Raw scores are converted to T-scores using scoring tables. A T-score of 50 is the average for the United States general population. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a T-score of 60 is one SD worse greater degree of fatigue than average. By comparison, a fatigue T-score of 40 is one SD better lesser degree of fatigue than average.

  3. 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

    This instrument consists of 8 self-report items focused on patient-reported involvement with peers in usual social roles, activities, and responsibilities. Items are rated on a 5-point likert scale ranging from 1 (Never Interacting) to 5 (Always Interacting). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For positively-worded concepts this measure, a T-score of 40 is one SD worse less interaction with peers than average. By comparison, a fatigue T-score of 60 is one SD better more interaction with peers than average.

  4. 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

    This instrument consists of 8 self-report items focused on patient-reported difficulties with basic cognitive abilities such as memory, attention, concentration, processing speed, and organization skill. Items are rated on a 5-point likert scale ranging from 1 (Not at all) to 5 (Very much). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For cognitive function, a T-score of 40 is one SD less difficulty than average. By comparison, a T-score of 60 is one SD more difficulty than average .

  5. 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

    This measure consists of four scale scores (General Academic Concern, Academic Problems, School Stresses, and Academic Subjects) and a cumulative score is generated for each of the 4 scales [0-3 - General Academic Concern (1 item, total score range 0-3), Academic Problems (14 items, total score range 0-42), School Stresses (6 items, total score range 0-6); 0-4 - Academic Subjects (4 items, total score range 0-16)], which in sum can be considered as a clinical measure to assess and monitor the academic needs of a student following concussion. Higher scores correlate with greater difficulty with academic needs.

  6. 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 levels of inflammatory cytokine associated with post concussive symptoms

  7. 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 levels of inflammatory cytokine associated with post concussive symptoms

  8. 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 levels of inflammatory cytokine associated with post concussive symptoms

  9. 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 levels of inflammatory cytokine associated with post concussive symptoms

  10. 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 levels of inflammatory cytokine associated with post concussive symptoms

  11. 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

    Salivary levels of inflammatory cytokine associated with post concussive symptoms

  12. 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

    Salivary DHEA concentration

    The high levels of DHEA that are secreted beginning in mid-childhood (~8 years of age) serve as a marker of adrenarche (puberty). DHEA level rises before external physical changes of puberty become obvious. Levels of DHEA in saliva have been shown to be a reliable index of blood levels in children and adolescents and are not dependent on time of day. DHEA age/sex-based reference ranges will be used to determine pubertal maturation. The assay results range from 10.2 pg/mL to 1000 pg/mL with higher levels correlating with later Tanner stages of puberty.

  13. Presence of genetic variants in genes that code for inflammatory cytokines

    Time frame: Within 7 days of injury

    Inflammatory genetic variants involved in brain injury and in fatigue in the following genes:

    APOE, IGSF3, IFN-γ, IL-1β, IL-6, IL-8, IL-10, MAPT, TNF-α, TNFAIP1, TNFAIP8

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Fitterer, MPH

CONTACT

[email protected]

Karin Reuter-Rice, PhD

CONTACT

[email protected]

919-681-7647

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: RSiCC

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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