Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT04874389
• Lead Sponsor: Clea Tucker

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.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Status Verified: 2021-05
• Study Start: 2021-05
• Study First Posted: 2021-05-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06
• Primary Completion: 2021-07
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide	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

Secondary Outcome Measures

Name	Time	Method
Advanced portability of functional objective testing in concussion	3-6 months for data acquisition and data analysis	Exploration of combined wearable tools to provide functional objective data that better reflect brain activity and possible impairments post concussion throughout brains recovery

Trial Locations

Locations (1)

California State University, Los Angeles; 🇺🇸 Los Angeles, California, United States