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

Running, not enrolling

Conditions studied: Concussion, Mild

In brief

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.

Key facts

Study ID

NCT04582682

Run by

Milton S. Hershey Medical Center

People needed

750

Starts

2021-01-18

Expected to finish

2027-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• > 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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