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NCT05379920 · ClinicalTrials.gov registry record · NA
Salivary Biomarkers for Concussion Recovery
A NA study of Concussion, Brain, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05379920: Completed NA study of Concussion, Brain, sponsored by State University of New York at Buffalo.
NCT05379920 is a NA study of Concussion, Brain that has completed, run by State University of New York at Buffalo. The registered enrollment target is 60 participants, below the 182-participant average among 20 other Concussion, Brain trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05379920, a NA study of Concussion, Brain, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
PPCS is defined as more recovery that occurs 28 days or more from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as asymptomatic, exercise tolerant and confirmation by independent medical examination.
Conditions Studied
Interventions
- BEHAVIORAL High Volume Aerobic Exercise
- BEHAVIORAL Low Volume Aerobic Exercise
Study Locations (1)
New York
- UB MD Orthopeadics & Sports Medicine - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2023-01-13 |
| Phase | NA |
What the finished NCT05379920 record still lists
NCT05379920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 182-participant average among 20 other Concussion, Brain trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Concussion, Brain appearing as the primary indexed condition, and to 2 interventions - of which High Volume Aerobic Exercise is the first listed.
NCT05379920 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05379920 about?
NCT05379920 is a clinical study titled "Salivary Biomarkers for Concussion Recovery". 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 significan...
What is the current status of trial NCT05379920?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-03-22. Estimated completion is 2023-01-13.
What conditions does trial NCT05379920 study?
This clinical trial studies the following conditions: Concussion, Brain.
What interventions are being tested in trial NCT05379920?
The interventions under investigation include: High Volume Aerobic Exercise (BEHAVIORAL), Low Volume Aerobic Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT05379920?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05379920 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05379920's enrollment target sits among peer trials
60 16th of 20 higher than 5 of 20 other Concussion, Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion, Brain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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