Salivary Biomarkers for Concussion Recovery (NCT05379920) | Clinical Trial Compass
CompletedNot Applicable
Salivary Biomarkers for Concussion Recovery
United States60 participantsStarted 2022-03-22
Plain-language summary
The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise. The investigators hypothesize salivary BDNF and specific miRNA signatures will change in a statistically significant manner as participants proceed from injury to recovery and participants who show recovery in ANS regulation will show significant differences in salivary BDNF and specific miRNA expression. This study also aims to determine if BDNF and/or specific miRNA can serve as biomarkers of the return of ANS function in concussed patients. The basic premise here is that the volume of exercise will significantly affect the rate of change in the expression of salivary BDNF and miRNA from injury to recovery.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
• Adolescent and adult athletes (age 13-18) diagnosed with SRC within 10 days of injury.
Exclusion Criteria:
* Evidence of focal neurological deficit;
* Inability to exercise because of orthopedic or cervical spine injury;
* Increased cardiac risk according to American College of Sports Medicine criteria;
* History of moderate or severe TBI, defined as brain injury with a Glasgow Coma Scale score of 12 or less;
* Current medication treatment for ADHD, learning disorders, depression, anxiety, or other medications that can affect HR;
* Symptom severity score of less than 5 on the initial visit Post Concussion Symptom Scale questionnaire. (7) currently pregnant (8) have any contraindications to exercise (Physical Activity Readiness-Questionnaire)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Persistent Post Concussion Symptoms (PPCS) (Yes/No)