N/A
N=60
Salivary Biomarkers for Concussion Recovery
Concussion, Brain
Bottom Line
View on ClinicalTrials.gov: NCT05379920 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Persistent Post Concussion Symptoms (PPCS) (Yes/No) — 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Volume Aerobic Exercise (Behavioral); Low Volume Aerobic Exercise (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistent Post Concussion Symptoms (PPCS) (Yes/No) |
4; 4 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05379920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.