Identifying RNA changes in saliva to predict concussion outcomes in children
Predicting Concussion Outcomes with Salivary MiRNA
This study is trying to see if changes in saliva can help predict how long kids with mild concussions will feel symptoms and how well treatments might work for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT02901821 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze salivary RNA expression in 600 children aged 5 to 21 who have experienced mild traumatic brain injury (mTBI) within the last week. By examining the RNA patterns, researchers hope to predict the duration and nature of concussive symptoms and the effectiveness of subsequent therapies. The study will also include 100 age- and gender-matched controls to better understand the RNA profiles associated with mTBI. The hypothesis is that specific RNAs will show differential regulation in children with prolonged symptoms compared to those with shorter recovery times.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 21 who have sustained a mild traumatic brain injury within the past week.
Not a fit: Patients with severe traumatic brain injury, skull fractures, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of concussion outcomes and tailored treatment strategies for children.
How similar studies have performed: Preliminary studies in adults have shown promise in using salivary RNA as biomarkers for TBI, but this approach in children is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 5-21 years with mild traumatic brain injury that occurred within 7 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
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Steven Hicks, MD, PhD — Milton S. Hershey Medical Center
- Study coordinator: Steven Hicks, MD, PhD
- Email: shicks1@hmc.psu.edu
- Phone: 7175318006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.