ACTIVE_NOT_RECRUITING

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

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Conditions

Concussion, Mild

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-18
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04582682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age at enrollment: 13-18 years of age (inclusive).
  1. * \> 48 hours after initial mTBI
  2. * Glasgow Coma Scale score of 13 or less
  3. * Previous moderate-to-severe TBI requiring overnight hospitalization
  4. * Unresolved symptoms from previous concussion, or any concussion within the last 3 months
  5. * Abbreviated Injury Scale (AIS) score \> 3 (to reduce confounding from poly-trauma)
  6. * Psychiatric illness requiring previous hospitalization;
  7. * Neurological condition (e.g. epilepsy, hydrocephalus) or abnormality on neuroimaging (if performed)
  8. * Intellectual disability that prevents ability to provide informed assent
  9. * Pregnancy
  10. * Active substance use/dependence
  11. * Previous neurosurgery
  12. * Non-fluency in English
  13. * Upper respiratory infection
  14. * Periodontal infection
  15. * Injury to the oropharynx
  16. * Previously enrolled in the same study
  17. * Inability to complete follow-up assessments

Contacts and Locations

Principal Investigator

Steve Hicks, MD, PhD
PRINCIPAL_INVESTIGATOR
Penn State University, College of Medicine

Study Locations (Sites)

Boston Children's Hosptial
Boston, Massachusetts, 02115
United States
Weill Cornell Medicine/ New York Presbyterian Hospital
New York, New York, 10021
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Steve Hicks, MD, PhD, PRINCIPAL_INVESTIGATOR, Penn State University, College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-18
Study Completion Date2026-01

Study Record Updates

Study Start Date2021-01-18
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Concussion, Mild