Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)

NCT04874389 | Unknown

• 1 other identifier: 1502994
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

brain oxygenation; functional multimodal assessment; dual tasking; traumatic brain injury; balance; gait; cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Advanced portability of functional objective testing in concussion

  3-6 months for data acquisition and data analysis

Study Arms (2)

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

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

Interventions

Multimodal Assessment DIAGNOSTIC_TEST

Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.

Also known as: 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; Recreationally active males and females

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clea Tucker: lead

Study Sites (1)

California State University, Los Angeles

Los Angeles, California, 90032, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Clea P Tucker, DPT

CONTACT

3233434641; ctucker@calstatela.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor; Doctor of Physical Therapy

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)