Concussion, BrainNCT05379920

Salivary Biomarkers for Concussion Recovery

A study testing High Volume Aerobic Exercise and Low Volume Aerobic Exercise in people with Concussion, Brain, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Concussion, Brain
What is being tested?: High Volume Aerobic Exercise and Low Volume Aerobic Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2022to 13 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

UB MD Orthopeadics & Sports Medicine
Buffalo, New York, 14214

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Concussion, Brain
Being tested: High Volume Aerobic Exercise, Low Volume Aerobic Exercise
Keywords: adolescent, exercise, aerobic, biomarker, recovery
Medical subject headings: Brain Concussion, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Volume Aerobic ExerciseBehavioural
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 ExerciseBehavioural
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.

Study groups in NCT05379920
Study group	Role	What they receive
Concussed Participants Group 1	Experimental	High Volume Group Receives: Behavioral: High Volume Aerobic Exercise
Concussed Participants Group 2	Experimental	Low Volume Group Receives: Behavioral: Low Volume Aerobic Exercise
Healthy controls Group 1	Active comparator	High Volume Group Receives: Behavioral: High Volume Aerobic Exercise
Healthy Controls Group 2	Active comparator	Low Volume Group Receives: Behavioral: Low Volume Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202213 Jan 2023

First posted18 May 2022
Study start22 Mar 2022
Primary completion13 Jan 2023
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Concussion, BrainStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Care provider
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05379920
Sponsor's protocol ID: STUDY00005734
Other IDs: UL1TR001412
Status last verified: Dec 2023
First submitted: 1 Mar 2022
Last updated: 3 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to share IPD currently

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Concussion, Brain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epigenetic and Cytokine Biomarkers During Recovery From Sports-Related Concussion
ClinicalTrials.gov ID: NCT05379920
Acronym / sponsor ID: STUDY00005734
Conditions: Concussion, Brain
Keywords: adolescent, exercise, aerobic, biomarker, recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 22 Mar 2022 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 18 May 2022 (actual)
Results: Posted 3 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 4
Model description: 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.

Arm	Type	Receives
Concussed Participants Group 1	Experimental	Behavioral: High Volume Aerobic ExerciseHigh Volume Group
Concussed Participants Group 2	Experimental	Behavioral: Low Volume Aerobic ExerciseLow Volume Group
Healthy controls Group 1	Active comparator	Behavioral: High Volume Aerobic ExerciseHigh Volume Group
Healthy Controls Group 2	Active comparator	Behavioral: Low Volume Aerobic ExerciseLow Volume Group

Who may qualify

Ages: 13 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Volume Aerobic ExerciseAerobic 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.	Behavioural	Concussed Participants Group 1, Healthy controls Group 1
Low Volume Aerobic ExerciseAerobic 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.	Behavioural	Concussed Participants Group 2, Healthy Controls Group 2

Primary outcome

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.

Results and safety

Results posted to the registry on 3 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Concussed Participants Group 1	17	17
Concussed Participants Group 2	15	10
Healthy Controls Group 1	15	15
Healthy Controls Group 2	13	13

Primary outcome: Persistent Post Concussion Symptoms (PPCS) (Yes/No)

Time frame: 28 days. Count of participants. Unit: Participants

Measure	Concussed Participants Group 1 n = 17	Concussed Participants Group 2 n = 15
Value	4	4

Adverse events

Time frame: Adverse events were monitored during the two week intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concussed Participants Group 1	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Concussed Participants Group 2	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Healthy Controls Group 1	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Healthy Controls Group 2	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan to share IPD currently

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Leddy, MD study director

University at Buffalo

Barry Willer, PhD study chair

University at Buffalo

Praveen Arany, DDS, PhD principal investigator

University at Buffalo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High Volume Aerobic Exercise and Low Volume Aerobic Exercise in people with Concussion, Brain, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistent Post Concussion Symptoms (PPCS) (Yes/No) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05379920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.