Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion

NCT ID: NCT04582682

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2026-06-30

Brief Summary

The purpose of this study is to identify changes in salivary micro ribonucleic acid (miRNA) levels that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.

Detailed Description

The objective of this multi-center study is to refine and validate a saliva RNA assessment for adolescent concussion, yielding a non-invasive test that predicts duration and character of symptoms, and helps guide clinical decisions. To accomplish this goal, the study will enroll 750 adolescents with mTBI. Saliva RNA levels and symptoms will be assessed at <48 hours, 7 days, and 30 days post-injury. Aim 1 will assess the ability of saliva RNA dynamics (Δ from <48 hours to day 7) to predict PPCS 30 days after mTBI (defined by persistence of ≥3 symptoms on day 30, compared with pre-injury state on the Post-Concussion Symptom Inventory; PCSI). RNA accuracy will be compared to a validated clinical prediction tool (5p tool). Aim 2 will assess the ability of saliva RNA dynamics (Δ from <48 hours to day 30) to identify recovered participants on day 30. RNA accuracy will be compared to change in composite score on a standardized reaction time test (from <48hrs to day 30). Completion of these aims will yield an objective biologic test that can be used for prognosis at the time of mTBI, and to aid clinical decisions regarding return-to-learn or return-to-play.

Conditions

Concussion, Mild

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Presence of mTBI: defined by criteria from the Berlin Consensus Statement and WHO. Assessment for mTBI status be performed by a licensed clinician per the 2018 CDC guidelines.
• Age at enrollment: 13-18 years of age (inclusive).

Exclusion Criteria

• > 48 hours after initial mTBI
• Glasgow Coma Scale score of 13 or less
• Previous moderate-to-severe TBI requiring overnight hospitalization
• Unresolved symptoms from previous concussion, or any concussion within the last 3 months
• Abbreviated Injury Scale (AIS) score > 3 (to reduce confounding from poly-trauma)
• Psychiatric illness requiring previous hospitalization;
• Neurological condition (e.g. epilepsy, hydrocephalus) or abnormality on neuroimaging (if performed)
• Intellectual disability that prevents ability to provide informed assent
• Pregnancy
• Active substance use/dependence
• Previous neurosurgery
• Non-fluency in English
• Upper respiratory infection
• Periodontal infection
• Injury to the oropharynx
• Previously enrolled in the same study
• Inability to complete follow-up assessments

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Hicks

Assistant Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steve Hicks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University, College of Medicine

Locations

Boston Children's Hosptial

Boston, Massachusetts, United States

Weill Cornell Medicine/ New York Presbyterian Hospital

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00016155

Identifier Type: -

Identifier Source: org_study_id