- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582682
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
February 13, 2024 updated by: Steven Hicks, Milton S. Hershey Medical Center
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steven Hicks, MD, PhD
- Phone Number: 7175318006
- Email: shicks1@pennstatehealth.psu.edu
Study Contact Backup
- Name: Brennen Harding, MS
- Phone Number: 284808 7175310003
- Email: bharding@pennstatehealth.psu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hosptial
-
Contact:
- John Shultz
- Email: John.Shultz@childrens.harvard.edu
-
Sub-Investigator:
- Rebekah Mannix, MD, MPH
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Weill Cornell Medicine/ New York Presbyterian Hospital
-
Contact:
- Dekeya Slaughter
- Phone Number: 646-962-8721
- Email: des4025@med.cornell.edu
-
Principal Investigator:
- Deborah Levine, MD
-
Syracuse, New York, United States, 13210
- Recruiting
- SUNY Upstate Medical University
-
Contact:
- Lauren Pacelli
- Email: PacelliL@upstate.edu
-
Sub-Investigator:
- Tyler Greenfield, DO
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Lynn Babcock
- Email: mailto:Lynn.Babcock@cchmc.org
-
Principal Investigator:
- Lynn Babcock, MD, MS
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Milton S. Hershey Medical Center
-
Contact:
- Brennen Harding, MS
- Phone Number: 280848 717-531-0003
- Email: bharding@pennstatehealth.psu.edu
-
Sub-Investigator:
- Steven Hicks, MD, PhD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children 13-18 years with mild traumatic brain injury
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concussion symptom burden and severity
Time Frame: Within 48 hours of injury, 7 days post-injury, and 30 days post-injury
|
measured as ranked scores by the PCSI at enrollment, 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.
Symptom burden will be number of symptoms experiencing and severity will be how sever those symptoms are on the 0-6 scale
|
Within 48 hours of injury, 7 days post-injury, and 30 days post-injury
|
Orientation, immediate memory, concentration, and delayed recall performance
Time Frame: Within 48 hours of injury
|
measured as ranked scores by the Standardized Assessment of Concussion (SAC) at enrollment, this test scores cognition using orientation (ex.
what is todays date), immediate memory (repeating a list of 10 words), concentration (repeating a list of 3-6 numbers backwards and the months of the year backwards), and delayed recall (recalling the list of 10 words from earlier).
Subject receives points for each correct answer with lower scores meaning the concussion has affect the subject more
|
Within 48 hours of injury
|
Balance performance
Time Frame: Within 48 hours of injury
|
measured by the Balance Error Scoring System (BESS) at enrollment, which includes scoring balance on foam and firm surfaces in three different stances for 20 seconds with eyes closed.
One point is give per error.
An error is credited to the subject when any of the following occur: moving the hands off of the iliac crests, opening the eyes, step stumble or fall, abduction or flexion of the hip beyond 30, lifting the forefoot or heel off of the testing surface, remaining out of the proper testing position for greater than 5 seconds.
The maximum total number of errors for any single condition is 10 with 3 conditions (double leg, single leg and tandem stances) each on each foam and firm surfaces the total maximum BESS score is 60 and the lowest score one can achieve is 0. With 0 being the best and 60 being the worst.
|
Within 48 hours of injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steve Hicks, MD, PhD, 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 Major Dates
Study Start (Actual)
January 18, 2021
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
October 5, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00016155
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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