Salivary Biomarkers for Concussion Recovery

NCT05379920 | Completed Results DMC

• 2 other identifiers: STUDY00005734UL1TR001412
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adolescent; exercise; aerobic; biomarker; recovery

Outcome Measures

Primary Outcomes (1)

• Persistent Post Concussion Symptoms (PPCS) (Yes/No)

  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.

  28 days

Study Arms (4)

Concussed Participants Group 1

EXPERIMENTAL

High Volume Group

Behavioral: High Volume Aerobic Exercise

Concussed Participants Group 2

EXPERIMENTAL

Low Volume Group

Behavioral: Low Volume Aerobic Exercise

Healthy controls Group 1

ACTIVE COMPARATOR

High Volume Group

Behavioral: High Volume Aerobic Exercise

Healthy Controls Group 2

ACTIVE COMPARATOR

Low Volume Group

Behavioral: Low Volume Aerobic Exercise

Interventions

High Volume Aerobic Exercise BEHAVIORAL

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.

Concussed Participants Group 1; Healthy controls Group 1

Low Volume Aerobic Exercise BEHAVIORAL

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.

Concussed Participants Group 2; Healthy Controls Group 2

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent and adult athletes (age 13-18) diagnosed with SRC within 10 days of injury.

You may not qualify if:

• 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)

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UB MD Orthopeadics & Sports Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Brain Concussion; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Results Point of Contact

• Title: Haley Chizuk
• Organization: University at Buffalo

haleychi@buffalo.edu

7162043200

Study Officials

• John Leddy, MD

  University at Buffalo

  STUDY DIRECTOR

• Barry Willer, PhD

  University at Buffalo

  STUDY CHAIR

• Praveen Arany, DDS, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Mohammad Nadir, MD, PhD

  University at Buffalo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned into 4-arms: (1) Concussed participants: high volume exercise, (2) Concussed participants: low volume exercise, (3) Healthy controls: high volume exercise, (4) Healthy controls: low volume exercise. Each group will consist of 50% males and 50% females. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT. The high-volume group will exercise aerobically at 90% of their HRt for 5 days a week for 30 minutes. The low volume group will exercise aerobically at 90% of their HRt for 3 days a week for 30 minutes. The intervention will last 2 weeks. Participants will return to the clinic and repeat testing on Days 7 and 14. Recovery is defined as (1) resolution of concussion symptoms (2) physical examination within normal limits; (3) ability to exercise to at least 80% of age-appropriate maximum HR without exacerbation of concussion-like symptoms on the BCTT.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: May 18, 2022
• Study Start: March 22, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)