Clinical trial NCT04582682: Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
Official title: Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Concussion, Mild
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-10-09
Enrollment: 750
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 13-18 years with mild traumatic brain injury

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.

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

Primary outcomes:
measure: Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
timeFrame: 30 days after injury
measure: Presence or absence of concussion recovery 30 days after injury
timeFrame: 30 days after injury
Secondary outcomes:
measure: Concussion symptom burden and severity
timeFrame: Within 48 hours of injury, 7 days post-injury, and 30 days post-injury
measure: Orientation, immediate memory, concentration, and delayed recall performance
timeFrame: Within 48 hours of injury
measure: Balance performance
timeFrame: Within 48 hours of injury
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hosptial
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine/ New York Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University, College of Medicine
name: Steve Hicks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: