Clinical trial NCT04874389: Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)
Official title: Multimodal Screening and Diagnostic Approaches to Brain Trauma in Performance Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Traumatic Brain Injury
Keywords: brain oxygenation
functional multimodal assessment
dual tasking
traumatic brain injury
balance
gait
cognition
Lead sponsor: California State University, Los Angeles
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 male and female athletes and performers will be invited to participate.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide
timeFrame: 3-6 months for data acquisition and data analysis
Secondary outcomes:
measure: Advanced portability of functional objective testing in concussion
timeFrame: 3-6 months for data acquisition and data analysis
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California State University, Los Angeles
state: California
Study officials:
References: