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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

Tracking Information
First Submitted Date September 12, 2016
First Posted Date September 15, 2016
Last Update Posted Date August 28, 2020
Study Start Date January 2016
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2019)
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)
Original Primary Outcome Measures
 (submitted: September 14, 2016)
Salivary microRNA profile [ Time Frame: once, at time of enrollment ]
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2019)
Salivary RNA profile [ Time Frame: Within 7d of initial injury, 1-2 weeks post-injury, and 4-weeks post-injury ]
measured with RNAseq
Original Secondary Outcome Measures
 (submitted: September 14, 2016)
concussion symptom duration [ Time Frame: at 4 weeks and 8 weeks post-injury ]
measured via phone interview with SCAT3 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Concussion Outcomes With Salivary miRNA
Official Title Predicting Concussion Outcomes With Salivary miRNA
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
salivary nucleic acids
Sampling Method Non-Probability Sample
Study Population Children 5-21 years with mild traumatic brain injury
Condition Concussion, Mild
Intervention Genetic: salivary RNA collection
collection of saliva for microRNA (small noncoding RNA) processing
Study Groups/Cohorts
  • Control
    No intervention. Collection of medical/demographic info and salivary RNA in children 5-21 years without history of mild traumatic brain injury (mTBI).
    Intervention: Genetic: salivary RNA collection
  • 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.
    Intervention: Genetic: salivary RNA collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2019)
700
Original Estimated Enrollment
 (submitted: September 14, 2016)
150
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Steven Hicks, MD, PhD 7175318006 shicks1@hmc.psu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02901821
Other Study ID Numbers STUDY00003729
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steven Hicks, Milton S. Hershey Medical Center
Study Sponsor Milton S. Hershey Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Steven Hicks, MD, PhD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date August 2020