Predicting Concussion Outcomes With Salivary miRNA

The purpose of this study is to characterize longitudinal salivary miRNA expression in 200
children with mTBI and identify miRNA patternsthat predict length, character, and severity of
concussive symptoms.

Hypothesis: Specific miRNAs will be differentially regulated in children with prolonged mTBI
symptoms. The investigators predict that a set of miRNAs 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 miRNA 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 miRNA profiles has not been explored. The
investigators propose to investigate these questions by examining salivary miRNA from 200
children (ages five to twenty-one years) with a clinical diagnosis of mTBI and 100 age-and
gender-matched controls, recruited from the Penn State Pediatric Concussion Clinic, Emergency
Department, and the affiliated primary care clinics (e.g. 35 Hope Drive). The investigators
plan to prospectively follow 200 children with mTBI for 1-month post-concussion, tracking
subjective symptoms with the Child Sports Concussion Assessment Tool (SCAT-5), and objective
symptoms with the ClearEdge balance/cognitive test. Saliva will be collected via swab at
three time-points (at initial clinical presentation, 2-, and 4-weeks after the date of
initial mTBI). Expression of salivary miRNA taken at initial presentation will be compared
against symptom duration (acute < 2 weeks, versus chronic > 2 weeks) and severity (as
measured numerically by SCAT-5 self-report and ClearEdge scoring). The investigators plan to
identify a set of salivary miRNAs that can easily be used to predict clinical course for
pediatric patients following a diagnosis of mTBI.

Inclusion Criteria:

- 5-21 years with mild traumatic brain injury that occurred within 14 days of enrollment

Exclusion Criteria:

- Sever traumatic brain injury

- Skull fracture

- Concurrent upper respiratory infection

- Patients whose primary language is not English

- Periodontal infection

- Wards of the state

- Ongoing seizure disorder,

- Drug or alcohol dependency