Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05379920 |
| Other study ID # |
STUDY00005734 |
| Secondary ID |
UL1TR001412 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
