- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825027
Risk Stratification in Children With Concussion (RSiCC)
A Risk Stratification Model for Health and Academic Outcomes in Children With Concussion Based on Novel Symptom Trajectory Typologies
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Karin Reuter-Rice, PhD
- Phone Number: 919-681-7647
- Email: karin.reuter-rice@duke.edu
Study Contact Backup
- Name: Amanda Fitterer, MPH
- Email: amanda.fitterer@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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 .
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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
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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
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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.
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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
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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
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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
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Presence of genetic variants in genes that code for inflammatory cytokines
Time Frame: Within 7 days of injury
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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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
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Salivary levels of inflammatory cytokine associated with post concussive symptoms
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karin Reuter-Rice, PhD, Duke University School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111606
- R01NS129617 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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