Salivary Biomarkers for Concussion Recovery

NCT05379920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-03

Study results available
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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.

Conditions

  • Concussion, Brain

Interventions

BEHAVIORAL

High Volume Aerobic Exercise

Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.

BEHAVIORAL

Low Volume Aerobic Exercise

Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • John Leddy, MD · University at Buffalo

  • Barry Willer, PhD · University at Buffalo

  • Praveen Arany, DDS, PhD · University at Buffalo

  • Mohammad Nadir, MD, PhD · University at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-01-13
Completion
2023-01-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379920 on ClinicalTrials.gov