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Saliva test may predict teen concussion recovery time

NCT ID NCT04582682

Knowledge-focused Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This study tracks 750 teens aged 13-18 with mild concussions to see if changes in their saliva can predict how long symptoms last. Researchers will check for persistent symptoms 30 days after injury. The goal is to find biological markers that help doctors personalize recovery plans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which teens will have long-lasting concussion symptoms, leading to better follow-up care.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear predictors, and results may not apply to all teens.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children 5-24 years with mild traumatic brain injury

Ages

5 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 5-24 years of age (inclusive). Exclusion Criteria: * \>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; * 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

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Concussion, mild

Contacts and locations

Locations

  • Boston Children's Hosptial

    Boston, Massachusetts, 02115, 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

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Weill Cornell Medicine/ New York Presbyterian Hospital

    New York, New York, 10021, United States

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