Salivary Biomarkers for Concussion Recovery

December 13, 2023 updated by: Praveen Arany, State University of New York at Buffalo

Epigenetic and Cytokine Biomarkers During Recovery From Sports-Related Concussion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • This is a four-arm randomized control trial that investigates the changes in expression of BDNF/ miRNA after prescribed exercise intervention in concussed adolescents. Potential participants will be selected from incoming patients to the University Concussion Management Clinic. For a patient to become a potential participant in the "concussed participant" group, a sports medicine physician must first confirm the diagnosis of an acute concussion within 10 days of injury. Healthy controls will be recruited at local high schools (pediatric) and from the UB Clinical Trial registry (pediatric and adult). Concussion diagnosis is based on history, a concussion symptom questionnaire, and a concussion-specific physical examination. If the participant's medical history and demographic information meet eligibility criteria, they will be asked if they would like to participate. All potential participants will be informed of all study procedures verbally. If participants are willing and eligible to participate, they will be asked to consent/ assent to the study procedure.
  • Participants will be asked to fill out the documentation regarding their demographics, concussion symptoms/history (Concussion Symptom Evaluation, Post-Concussion Symptom Inventory), and motivation to exercise (Modified Perceived Competence Scale, Modified Treatment Self-Regulation Questionnaire). Additionally, to determine if participants have any contraindications to exercise, the Physical Activity Readiness Questionnaire (PAR-Q) will be completed by all participants.
  • Participants will undergo the Buffalo Concussion Physical Exam (BCPE), a short examination to used determine if a patient is concussed. This examination includes vital signs, a head and neck examination, cranial nerve testing, oculomotor testing, and a balance test.
  • A trained examiner will complete an Oral Hygiene Index-Simplified (OHI-S) and will collect saliva. The Oral Hygiene Index is a short evaluation of the calculus and debris on selected teeth to assess the oral hygiene of a participant. Saliva will be collected using a Genotek Swab (miRNA) and a Salimetrics Cryovial (BDNF). Saliva will be collected with a swab (Genotek) and passive drool (Salimetrics) techniques.
  • After saliva is obtained, the participant will be asked to complete the Buffalo Concussion Treadmill Test (BCTT). The BCTT is a graded exercise test that is used to determine concussion-related exercise intolerance. Although it is standard for patients from the Concussion Clinic to require a BCTT assessment as a part of their standard visit, participants will be made aware that their BCTT data will be used for this study. During the BCTT participants will be asked to wear an HR monitor (Polar H10) for the collection of HR and Heart Rate Variability (HRV) data.
  • After completion of the BCTT, the examiner will use the results of the exercise test to create an individualized exercise prescription. The prescription will be randomized for high and low volumes and even split between male and female participants in healthy and concussed groups.
  • Recovery date for concussed participants will be provided by the study clinician after the end of the intervention if concussed participants do not recover during the study time frame.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • UB MD Orthopeadics & Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Concussed Participants Group 1
High Volume Group
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.
Experimental: Concussed Participants Group 2
Low Volume Group
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.
Active Comparator: Healthy controls Group 1
High Volume Group
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.
Active Comparator: Healthy Controls Group 2
Low Volume Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Persistent Post Concussion Symptoms (PPCS) (Yes/No)
Time Frame: 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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: John Leddy, MD, University at Buffalo
  • Study Chair: Barry Willer, PhD, University at Buffalo
  • Principal Investigator: Praveen Arany, DDS, PhD, University at Buffalo
  • Study Director: Mohammad Nadir, MD, PhD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005734
  • UL1TR001412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD currently

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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