Predicting Concussion Outcomes With Salivary miRNA
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ClinicalTrials.gov Identifier: NCT02901821 |
Recruitment Status :
Recruiting
First Posted : September 15, 2016
Last Update Posted : August 28, 2020
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Condition or disease | Intervention/treatment |
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Concussion, Mild | Genetic: salivary RNA collection |
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.
Study Type : | Observational |
Estimated Enrollment : | 700 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Predicting Concussion Outcomes With Salivary miRNA |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | September 2025 |
Estimated Study Completion Date : | September 2025 |

Group/Cohort | Intervention/treatment |
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Control
No intervention. Collection of medical/demographic info and salivary RNA in children 5-21 years without history of mild traumatic brain injury (mTBI).
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Genetic: salivary RNA collection
collection of saliva for microRNA (small noncoding RNA) processing |
Concussion
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.
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Genetic: salivary RNA collection
collection of saliva for microRNA (small noncoding RNA) processing |
- Presence or absence of concussion symptoms [ Time Frame: 4-weeks post injury ]subjective (score >7 on PCSI) or objective (score outside 85 percentile on accelerometer balance testing or cognitive testing)
- Salivary RNA profile [ Time Frame: Within 7d of initial injury, 1-2 weeks post-injury, and 4-weeks post-injury ]measured with RNAseq
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 5 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901821
Contact: Steven Hicks, MD, PhD | 7175318006 | shicks1@hmc.psu.edu |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Steven Hicks, MD, PhD 717-531-8006 shicks1@hmc.psu.edu |
Principal Investigator: | Steven Hicks, MD, PhD | Milton S. Hershey Medical Center |
Responsible Party: | Steven Hicks, Assistant Professor of Pediatrics, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT02901821 |
Other Study ID Numbers: |
STUDY00003729 |
First Posted: | September 15, 2016 Key Record Dates |
Last Update Posted: | August 28, 2020 |
Last Verified: | August 2020 |
Brain Concussion Brain Injuries, Traumatic Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds and Injuries Wounds, Nonpenetrating |