NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
Active Not RecruitingN/A
Sponsor: Milton S. Hershey Medical Center
Conditions: Concussion, Mild
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 5 Years to 24 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
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: 5-24 years of age (inclusive). Exclusion Criteria: * \>7d 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
Locations (5)
- Boston, Massachusetts, United States
- New York, New York, United States
- Syracuse, New York, United States
- Cincinnati, Ohio, United States
- Hershey, Pennsylvania, United States