An observational study in Concussion, Mild, sponsored by Milton S. Hershey Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Milton S. Hershey Medical Center · Observational
The purpose of this study is to identify changes in salivary ribosomal nucleic acid (RNA) expression that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.
The purpose of this study is to characterize longitudinal salivary RNA expression in 600 children with mTBI and identify RNA patterns that predict length and characterof concussive symptoms, as well as the response to therapy.
Hypothesis: Specific RNAs will be differentially regulated in children with prolonged mTBI symptoms across the acute and sub-acute time periods. The investigators predict that a set of RNAs with differential expression in children with mTBI will be statistically associated with functional measures of mTBI symptoms as well as the duration of concussive symptoms.
Rationale: Preliminary studies show that miRNA is altered in adults with varying degrees of TBI and that salivary RNA is altered by disorders of the CNS. These studies indicate that serum-based miRNA may be used as an accurate biomarker for differentiating adults with and without TBI. Whether similar patterns can seen in the saliva of children following mTBI remains to be seen. Furthermore, the influence of confounding variables such as gender, mechanism of injury, and previous mTBIs on RNA profiles has not been explored. The investigators propose to investigate these questions by examining salivary RNA from 600 children (ages five to twenty-one years) with a clinical diagnosis of mTBI (as well as 100 age-and gender-matched controls, recruited from the Penn State Pediatric Concussion Clinic, Emergency Department, and the affiliated primary care clinics). The investigators plan to prospectively follow 600 children with mTBI for 1-month post-concussion, tracking subjective symptoms with the Child Sports Concussion Assessment Tool (SCAT-5), and objective symptoms of balance and cognition. Saliva will be collected via swab at three time-points (at initial clinical presentation, 1-2 weeks, and 4-weeks after the date of initial mTBI). Expression of salivary RNA taken at initial presentation will be compared against symptom duration (where prolonged post-concussive symptoms are defined as those lasting >4 weeks) and character (as measured numerically by Post-concussion symptom inventory self-report and ClearEdge scoring). The investigators plan to identify a set of salivary RNAs that can easily be used to predict clinical course for pediatric patients following a diagnosis of mTBI.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's planned enrollment of 700 is above the median of 180 across 146 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children 5-21 years with mild traumatic brain injury
Exclusion Criteria:
No intervention. Collection of medical/demographic info and salivary RNA in children 5-21 years without history of mild traumatic brain injury (mTBI).
Genetic: salivary RNA collection
Collection of medical/demographic info and salivary RNA in children 5-21 years with history of mild traumatic brain injury (mTBI). Collection of PCSI concussion assessment interview tool and balance/cognition testing at time of injury, 1-2wks post injury, and 4wks post injury.
Genetic: salivary RNA collection
collection of saliva for microRNA (small noncoding RNA) processing
Presence or absence of concussion symptoms
subjective (score \>7 on PCSI) or objective (score outside 85 percentile on accelerometer balance testing or cognitive testing)
Time frame: 4-weeks post injury
Salivary RNA profile
measured with RNAseq
Time frame: Within 7d of initial injury, 1-2 weeks post-injury, and 4-weeks post-injury
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Milton S. Hershey Medical Center