Concussion, MildNCT04582682
Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
An observational study of Concussion, Mild, run by Milton S. Hershey Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 24 years
- Conditions the study is for
- Concussion, Mild
- How many people
- 750 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jan 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children 5-24 years with mild traumatic brain injury
Who may be able to join
- 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: 5-24 years of age (inclusive).
Who cannot join
- >7d 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;
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Children's Hosptial
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Weill Cornell Medicine/ New York Presbyterian Hospital
New York, New York, 10021
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
Read the detailed description
The objective of this multi-center study is to refine and validate a saliva RNA assessment for youth 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 youth with mTBI. Saliva RNA levels and symptoms will be assessed at enrollment, 7 days, and 30 days post-injury. Aim 1 will assess the ability of saliva RNA to predict PPCS 30 days after mTBI (defined by reliable change index, or persistence of ≥2 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 levels to identify recovered participants on day 30. RNA accuracy will be compared to change in composite score on a standardized reaction time test (from enrollment 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.
- Conditions
- Concussion, Mild
- Medical subject headings
- Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
PPCS will be defined by reliable change index on day 30, compared with pre-injury state, which will be determined from pre-injury symptoms reported at enrollment using the Post-Concussion Symptom Scale (PCSS). PCSS 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.
Measured: 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.
Measured: 30 days after injury
Secondary outcomes (3)
Concussion symptom burden and severity
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
Measured: Within 48 hours of injury, 7 days post-injury, and 30 days post-injury
Orientation, immediate memory, concentration, and delayed recall performance
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
Measured: Within 48 hours of injury
Balance performance
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.
Measured: Within 48 hours of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start18 Jan 2021
- Primary completion1 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Steven Hicks, Milton S. Hershey Medical Center
- Investigators
- Steve Hicks, MD, PhD, Principal investigator, Penn State University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582682
- Sponsor's protocol ID
- STUDY00016155
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
- ClinicalTrials.gov ID
- NCT04582682
- Acronym / sponsor ID
- STUDY00016155
- Conditions
- Concussion, Mild
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 youth 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 youth with mTBI. Saliva RNA levels and symptoms will be assessed at enrollment, 7 days, and 30 days post-injury. Aim 1 will assess the ability of saliva RNA to predict PPCS 30 days after mTBI (defined by reliable change index, or persistence of ≥2 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 levels to identify recovered participants on day 30. RNA accuracy will be compared to change in composite score on a standardized reaction time test (from enrollment 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children 5-24 years with mild traumatic brain injury
Key inclusion criteria (2 listed)
- 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: 5-24 years of age (inclusive).
Key exclusion criteria (17 listed)
- >7d 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
Time frame: 30 days after injury
PPCS will be defined by reliable change index on day 30, compared with pre-injury state, which will be determined from pre-injury symptoms reported at enrollment using the Post-Concussion Symptom Scale (PCSS). PCSS 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.
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.
3 secondary outcomes
Concussion symptom burden and severity
Time frame: 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
Balance performance
Time frame: Within 48 hours of injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Related trials for Concussion, Mild
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Hicks, MD, PhD principal investigator
Penn State University, College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild, run by Milton S. Hershey Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury (time frame: 30 days after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.