Risk Stratification in Children With Concussion

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-17
SponsorDuke University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with concussion that occurred within the past 7 days

Glasgow Coma Scale (GCS) score between 13-15

English speaking

Disqualifiers

Diagnosed with moderate or severe traumatic brain injury

Polytrauma

Nontraumatic brain injury

Pregnancy

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

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
2

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.

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
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

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.

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
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

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 .

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator