An observational study in Mild Traumatic Brain Injury, sponsored by Clea Tucker. Status unknown at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Clea Tucker · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with Clea Tucker as lead sponsor.
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50 male and female athletes and performers will be invited to participate.
Exclusion Criteria:
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 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.
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
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
Time frame: 3-6 months for data acquisition and data analysis
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
Time frame: 3-6 months for data acquisition and data analysis
Plan to share: No
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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