Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05379920
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2022-03-01
Brief Title:
Salivary Biomarkers for Concussion Recovery
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Epigenetic and Cytokine Biomarkers During Recovery From Sports-Related Concussion
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching purpose of this proposed research is to determine whether BDNF andor 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 andor 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
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 participants 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 symptomshistory 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
Participants will be asked to fill out the documentation regarding their demographics concussion symptomshistory 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR001412 | NIH | None | httpsreporternihgovquickSearchUL1TR001412 |