Salivary Biomarkers for Concussion Recovery
NCT05379920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-01-03
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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