Predicting Concussion Outcomes With Salivary miRNA

NCT02901821 | Active Not Recruiting DMC

• 1 other identifier: STUDY00003729
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

• Presence or absence of concussion symptoms

  subjective (score \>7 on PCSI) or objective (score outside 85 percentile on accelerometer balance testing or cognitive testing)

  4-weeks post injury

Secondary Outcomes (1)

• Salivary RNA profile

  Within 7d of initial injury, 1-2 weeks post-injury, and 4-weeks post-injury

Study Arms (2)

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

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

Interventions

salivary RNA collection GENETIC

collection of saliva for microRNA (small noncoding RNA) processing

Concussion; Control

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children 5-21 years with mild traumatic brain injury

You may qualify if:

• years with mild traumatic brain injury that occurred within 7 days of enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

salivary nucleic acids

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Hicks, MD, PhD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)