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

NCT04582682 | Active Not Recruiting

• 1 other identifier: STUDY00016155
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 5

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.

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (2)

• Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury

  PPCS will be defined by persistence of at least 3 symptoms on day 30, compared with pre-injury state, which will be determined from pre-injury symptoms reported at enrollment using the Post-Concussion Symptom Inventory (PCSI). PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe. A high score is indicative of a subject experiencing the worst they have experienced this symptom.

  30 days after injury

• Presence or absence of concussion recovery 30 days after injury

  Defined as a score of 0 (no difference) on item 22 of the Post-Concussion Symptom Inventory (PCSI); "To what degree do you feel 'differently' than before your injury?" This patient-oriented outcome measure relies on the individual's experience of symptoms to define recovery.PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe.

  30 days after injury

Secondary Outcomes (3)

• Concussion symptom burden and severity

  Within 48 hours of injury, 7 days post-injury, and 30 days post-injury

• Orientation, immediate memory, concentration, and delayed recall performance

  Within 48 hours of injury

• Balance performance

  Within 48 hours of injury

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children 13-18 years with mild traumatic brain injury

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (5)

Boston Children's Hosptial

Boston, Massachusetts, 02115, United States

Location

Weill Cornell Medicine/ New York Presbyterian Hospital

New York, New York, 10021, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Steve Hicks, MD, PhD

  Penn State University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 9, 2020
• Study Start: January 18, 2021
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-02

Locations

US (5)