Mild Traumatic Brain InjuryNCT04874389
Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)
An observational study of Mild Traumatic Brain Injury, run by Clea Tucker at 1 site in United States.
Trial summary
This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Multimodal Assessment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Adult
Study population: 50 male and female athletes and performers will be invited to participate.
Who may be able to join
- Recreationally healthy and active or considered an athletic performer, males and females, to regularly engage in >150 min/week of physical activity.
- Participants considered an athletic performer if they have history of participating in athletics at the university, amateur, elite or professional level, or are a military veteran.
- Healthy participants defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgement or inability to make sound decisions within the last 12 months.
- Post concussion participants are eligible if their last concussive event occurred within a month and up to 5 years of the date of data collection.
Who cannot join
- If younger than 18 or >50 years of age.
- Current cardiovascular, metabolic, psychiatric, or neurologic disease or cognitive or substance-abuse problems or taking medications that may impair cognition, balance, or functional mobility such as gait.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California State University, Los Angeles
Los Angeles, California, 90032
Clea P Tucker, DPT, 323-343-4641, ctucker@calstatela.edu
About this study
Official title: Multimodal Screening and Diagnostic Approaches to Brain Trauma in Performance Populations
This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. These mobile tools would also enable clinicians to test the effectiveness of the interventions used post-concussion, prior to fully releasing the performer back into full performance/active status.
Read the detailed description
Participants will have study benefits and risks explained to them and after consent has been obtained each participant will be assigned an Identification number and attend their assigned testing day.
Testing day will consist of completing a seven page clinician-created medical-health questionnaire to determine that they are free of cardiovascular, metabolic, psychiatric or neurologic disease, do not have cognitive or substance-abuse problems or are taking any medications that may impair cognition, balance or functional mobility such as gait.
Participants will also complete the Brain Injury Screening Questionnaire (BISQ, Mount Sinai School of Medicine, New York, NY) to additionally screen for lifetime history of traumatic brain injury (TBI) and reduce consequences of undiagnosed mTBI.
Tests will then be conducted in three parts. First, to evaluate neuromotor and neurocognitive abilities, participants will complete a modified balance error test and a modified version of the dynamic gait index without and with additional cognitive tasks. These tests will be performed while wearing external sensors recording kinematic data and a (wearable) functional near-infrared spectroscopy cap system (NIRSport1) unit monitoring brain tissue oxygenation and perfusion.
Second test that the above multimodal test will be compared to is the sport concussion assessment tool (SCAT 5).
The third test conducted and used to compare the multimodal approach to will be the Immediate post-concussion and cognitive testing (ImPACT).
Participants will be allotted a 15-minute break period between each test.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Multimodal Assessment
- Keywords
- brain oxygenation, functional multimodal assessment, dual tasking, traumatic brain injury, balance, gait, cognition
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal AssessmentDiagnostic test
Also called Immediate Post-Concussion and Cognitive Testing (ImPACT), Sport Concussion Assessment Tool (SCAT 5), Brain Injury Screening Questionnaire (BISQ), Combined Functional near-infrared spectroscopy (fNIRS) with external kinematic sensors +modified Balance Error Scoring System (mBESS) and modified Dynamic Gait Index (mDGI) _ cognitive tasks
Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.
| Study group | Role | What they receive |
|---|---|---|
| Recreationally active males and females | Subjects to be considered recreationally must regularly engage in >150 min/wk of physical activity (e.g., resistance training, sport or activity specific exercise, group exercise, or aerobic exercise). Healthy participants, defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgment or inability to make sound decisions or mild traumatic brain injury (mTBI, also commonly named "concussion") within the last 12 months. Receives: Diagnostic Test: Multimodal Assessment | |
| Athletes or performing artists with reported history of concussion | Participants will be considered if they are recreationally active or considered an athletic performer (i.e.,history of participation in athletics at the university, amateur, elite or professional levels, or a military veteran), or a performing artist (i.e., stunt actors, circus artists, dancers or acrobats) with reported history of concussion incident(s), with most recent incident occurring >1 month and less than five years from the study testing dates. Receives: Diagnostic Test: Multimodal Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide
Demonstrate functional objective measures can be used regardless of time since injury to provide improved clinical diagnosis, determinant of injury, remanence of injury events still occurring
Measured: 3-6 months for data acquisition and data analysis
Secondary outcomes (1)
Advanced portability of functional objective testing in concussion
Exploration of combined wearable tools to provide functional objective data that better reflect brain activity and possible impairments post concussion throughout brains recovery
Measured: 3-6 months for data acquisition and data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study startMay 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clea Tucker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clea Tucker, California State University, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874389
- Sponsor's protocol ID
- 1502994
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Screening and Diagnostic Approaches to Brain Trauma in Performance Populations
- ClinicalTrials.gov ID
- NCT04874389
- Acronym / sponsor ID
- 1502994
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- brain oxygenation, functional multimodal assessment, dual tasking, traumatic brain injury, balance, gait, cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clea TuckerUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. These mobile tools would also enable clinicians to test the effectiveness of the interventions used post-concussion, prior to fully releasing the performer back into full performance/active status.
Detailed description
Participants will have study benefits and risks explained to them and after consent has been obtained each participant will be assigned an Identification number and attend their assigned testing day.
Testing day will consist of completing a seven page clinician-created medical-health questionnaire to determine that they are free of cardiovascular, metabolic, psychiatric or neurologic disease, do not have cognitive or substance-abuse problems or are taking any medications that may impair cognition, balance or functional mobility such as gait.
Participants will also complete the Brain Injury Screening Questionnaire (BISQ, Mount Sinai School of Medicine, New York, NY) to additionally screen for lifetime history of traumatic brain injury (TBI) and reduce consequences of undiagnosed mTBI.
Tests will then be conducted in three parts. First, to evaluate neuromotor and neurocognitive abilities, participants will complete a modified balance error test and a modified version of the dynamic gait index without and with additional cognitive tasks. These tests will be performed while wearing external sensors recording kinematic data and a (wearable) functional near-infrared spectroscopy cap system (NIRSport1) unit monitoring brain tissue oxygenation and perfusion.
Second test that the above multimodal test will be compared to is the sport concussion assessment tool (SCAT 5).
The third test conducted and used to compare the multimodal approach to will be the Immediate post-concussion and cognitive testing (ImPACT).
Participants will be allotted a 15-minute break period between each test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recreationally active males and females | – | Diagnostic Test: Multimodal AssessmentSubjects to be considered recreationally must regularly engage in >150 min/wk of physical activity (e.g., resistance training, sport or activity specific exercise, group exercise, or aerobic exercise). Healthy participants, defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgment or inability to make sound decisions or mild traumatic brain injury (mTBI, also commonly named "concussion") within the last 12 months. |
| Athletes or performing artists with reported history of concussion | – | Diagnostic Test: Multimodal AssessmentParticipants will be considered if they are recreationally active or considered an athletic performer (i.e.,history of participation in athletics at the university, amateur, elite or professional levels, or a military veteran), or a performing artist (i.e., stunt actors, circus artists, dancers or acrobats) with reported history of concussion incident(s), with most recent incident occurring >1 month and less than five years from the study testing dates. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 50 male and female athletes and performers will be invited to participate.
Key inclusion criteria (4 listed)
- Recreationally healthy and active or considered an athletic performer, males and females, to regularly engage in >150 min/week of physical activity.
- Participants considered an athletic performer if they have history of participating in athletics at the university, amateur, elite or professional level, or are a military veteran.
- Healthy participants defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgement or inability to make sound decisions within the last 12 months.
- Post concussion participants are eligible if their last concussive event occurred within a month and up to 5 years of the date of data collection.
Key exclusion criteria (2 listed)
- If younger than 18 or >50 years of age.
- Current cardiovascular, metabolic, psychiatric, or neurologic disease or cognitive or substance-abuse problems or taking medications that may impair cognition, balance, or functional mobility such as gait.
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 |
|---|---|---|
| Multimodal AssessmentAlso: Immediate Post-Concussion and Cognitive Testing (ImPACT), Sport Concussion Assessment Tool (SCAT 5), Brain Injury Screening Questionnaire (BISQ), Combined Functional near-infrared spectroscopy (fNIRS) with external kinematic sensors +modified Balance Error Scoring System (mBESS) and modified Dynamic Gait Index (mDGI) _ cognitive tasksParticipants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations. | Diagnostic test | Athletes or performing artists with reported history of concussion, Recreationally active males and females |
Primary outcome
Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide
Time frame: 3-6 months for data acquisition and data analysis
Demonstrate functional objective measures can be used regardless of time since injury to provide improved clinical diagnosis, determinant of injury, remanence of injury events still occurring
1 secondary outcome
Advanced portability of functional objective testing in concussion
Time frame: 3-6 months for data acquisition and data analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Clea Tucker 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clea P Tucker, DPT (3233434641, ctucker@calstatela.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide (time frame: 3-6 months for data acquisition and data analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.