Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion (NCT04582682) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
United States750 participantsStarted 2021-01-18
Plain-language 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.
Who can participate
Age range13 Years – 18 Years
SexALL
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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
What they're measuring
1
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
Timeframe: 30 days after injury
2
Presence or absence of concussion recovery 30 days after injury