Identifying saliva biomarkers to predict recovery from adolescent concussions

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

This study is testing if changes in saliva can help predict how long it will take for teenagers to recover from concussions and what symptoms they might have.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 13 Years to 18 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT04582682 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify changes in salivary micro ribonucleic acid (miRNA) levels that can predict the duration and character of symptoms following mild traumatic brain injury (mTBI) in adolescents. By enrolling 750 participants aged 13-18, the study will assess saliva RNA levels and symptoms at various intervals post-injury. The goal is to develop a non-invasive test that can guide clinical decisions regarding recovery and return-to-learn or return-to-play protocols. The study will compare RNA dynamics with established clinical prediction tools to validate its effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 13-18 who have recently sustained a mild traumatic brain injury.

Not a fit: Patients who have sustained a moderate-to-severe traumatic brain injury or have unresolved symptoms from previous concussions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable, non-invasive method for predicting recovery timelines in adolescents with concussions.

How similar studies have performed: While the approach of using saliva RNA as a biomarker is innovative, similar studies have not been widely conducted, making this a novel investigation.

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

Where this trial is running

Boston, Massachusetts and 4 other locations

• Boston Children's Hosptial — Boston, Massachusetts, United States (Recruiting)
• Weill Cornell Medicine/ New York Presbyterian Hospital — New York, New York, United States (Recruiting)
• SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Steve Hicks, MD, PhD — Penn State University, College of Medicine
• Study coordinator: Steven Hicks, MD, PhD

Conditions Concussion, Mild