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NCT05379920

Salivary Biomarkers for Concussion Recovery

Completed NA Results posted Last updated 3 January 2024
What this trial tests

NA trial testing High Volume Aerobic Exercise in Concussion, Brain in 60 participants. Completed in 13 January 2023.

Timeline
22 March 2022
Primary endpoint
13 January 2023
13 January 2023

Quick facts

Lead sponsorState University of New York at Buffalo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date22 March 2022
Primary completion13 January 2023
Estimated completion13 January 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

State University of New York at Buffalo

Who can join

Adults 13 to 18, any sex, with Concussion, Brain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Persistent Post Concussion Symptoms (PPCS) (Yes/No) Primary · 28 days

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.

GroupValue95% CI
Concussed Participants Group 14
Concussed Participants Group 24

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Sex Differences in Response to Low- Versus High-Volume Aerobic Exercise for Sport-Related Concussion: A Pilot Randomized Controlled Trial.
    Chizuk HM, Castro E, Robinson S, Sayeed J, et al · · 2025 · cited 2× · PMID 40237613 · DOI 10.1097/htr.0000000000001061

Verify or expand the search:

Other recruiting trials for Concussion, Brain

Currently open trials in the same condition.

Other State University of New York at Buffalo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05379920.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing