Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: Multimodal Assessment

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Clea P Tucker, DPT; Phone Number: 3233434641; Email: ctucker@calstatela.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90032
      • Recruiting
      • California State University, Los Angeles
      • Contact: Clea P Tucker, DPT; Phone Number: 323-343-4641; Email: ctucker@calstatela.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50 male and female athletes and performers will be invited to participate.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Multimodal Assessment; Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.; Other Names: 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
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.	Diagnostic test: Multimodal Assessment; Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-6 months for data acquisition and data analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-6 months for data acquisition and data analysis

Collaborators and Investigators

• Sponsor: Clea Tucker

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (ACTUAL): May 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: gait; cognition; traumatic brain injury; balance; brain oxygenation; functional multimodal assessment; dual tasking
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 1502994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No