Risk Stratification in Children With Concussion

NCT05825027 | Recruiting

• 2 other identifiers: Pro00111606R01NS129617
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (13)

• Change in concussion symptom burden and severity as measured by the Post Concussion Symptom Scale (PCSS)

  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.

  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

  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.

  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

  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.

  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

  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 .

  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)

  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.

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  Salivary levels of inflammatory cytokine associated with post concussive symptoms

  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

  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.

  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

  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

  Within 7 days of injury

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from concussion clinics in the Raleigh-Durham metro area of North Carolina.

You may qualify if:

• Diagnosed with concussion that occurred within the past 7 days
• Glasgow Coma Scale (GCS) score between 13-15
• English speaking

You may not qualify if:

• Diagnosed with moderate or severe traumatic brain injury
• Polytrauma
• Nontraumatic brain injury
• Pregnancy

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

• Reuter-Rice K, Fitterer AN, Duquette P, Yang Q, Palipana AK, Laskowitz D, Garrett ME, Fletcher M, Smith J, Makor L, Grant G, Ramsey K, Bloom OJ, Ashley-Koch AE. A study protocol for risk stratification in children with concussion (RSiCC): Theoretical framework, design, and methods. PLoS One. 2024 Jul 18;19(7):e0306399. doi: 10.1371/journal.pone.0306399. eCollection 2024.

  PMID: 39024215 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Karin Reuter-Rice, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Reuter-Rice, PhD

CONTACT

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

Amanda Fitterer, MPH

CONTACT

amanda.fitterer@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 24, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)