Salivary Biomarkers for Concussion Recovery

Concussion, Brain Clinical Trial

Official title:

Epigenetic and Cytokine Biomarkers During Recovery From Sports-Related Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379920
• Other study ID #: STUDY00005734
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: December 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UB MD Orthopeadics & Sports Medicine	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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