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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
Sponsor:
Information provided by (Responsible Party):
Steven Hicks, Milton S. Hershey Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Concussion, Mild Genetic: salivary RNA collection

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Control
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 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.
 Genetic: salivary RNA collection
collection of saliva for microRNA (small noncoding RNA) processing


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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
salivary nucleic acids

Eligibility Criteria
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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
Study Population
Children 5-21 years with mild traumatic brain injury
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Steven Hicks, MD, PhD 7175318006 shicks1@hmc.psu.edu

Locations
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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   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Steven Hicks, MD, PhD Milton S. Hershey Medical Center
More Information
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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
Additional relevant MeSH terms:
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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