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Brain Injury Assessment Study at Hennepin County Medical Center (BASH)

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ClinicalTrials.gov Identifier: NCT02706574
Recruitment Status : Enrolling by invitation
First Posted : March 11, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
Hennepin County Medical Center, Minneapolis
Abbott Diagnostics Division
Minnesota Office of Higher Education- SCI and TBI Research Grant Program
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Brief Summary:
The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.

Condition or disease
Traumatic Brain Injury

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Injury Assessment Study at Hennepin County Medical Center
Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Isolated Traumatic Brain Injury
This group will present to our Level 1 Trauma Center with a Traumatic Brain Injury and no other associated injuries. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.
Isolated Body Trauma
This group will present to our Level 1 Trauma Center as a trauma patient with no injury to their head. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.
Combined Traumatic Brain Injury and Body Trauma
This group will present to our Level 1 Trauma Center as a trauma patient that had injuries to both their head and body. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.
Healthy, Uninjured Controls
This group will consist of subjects that have not been exposed to any major trauma in the previous 12 months. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.



Primary Outcome Measures :
  1. Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking [ Time Frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. ]
    Patients will watch a video for 220 seconds as it moves clockwise around the perimeter of a monitor at about 10 seconds per side, resulting in 5 complete rotations of 40 seconds each. As the patient watches the video, their eye movements will be recorded by a camera.

  2. Change in Proteomic Concentrations of Blood-Based Biomarkers during Recovery as Measured by Blood Draws [ Time Frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. ]
    Blood will be drawn for proteomic analysis at each follow-up time point. Blood will also be drawn acutely for genomic analysis.

  3. Change in Observable Neural Abnormalities as measured by Magnetic Resonance Imaging [ Time Frame: Post-Injury Time Points of Data Collection: within 1 week and at 1 year. ]
    A group of patients will be selected based on presenting symptoms to undergo a MRI within a week of their injury and again 1 year after their injury. The sequences for these scans will include T2 Flair, susceptibility weighted imaging, diffusion weighted imaging, and diffusion tensor imaging.

  4. Computed Tomography Scan [ Time Frame: Post-Injury Time Point of Data Collection: 1 year. ]
    A group of patients that had an acute CT scan at admission will be selected based on presenting symptoms to undergo a CT scan at 1 year post-injury.


Secondary Outcome Measures :
  1. Change in Neurological Examination during Recovery as Measured by the Neurological Outcome Scale after Traumatic Brain Injury [ Time Frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. ]
    The Neurological Outcome Scale for Traumatic Brain Injury is a standardized neurological examination validated specifically for patients with Traumatic Brain Injury.

  2. Change in Cognitive Function and Symptom Severity during Recovery as Measured with the Sports Concussion Assessment Tool 3 (SCAT3) [ Time Frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. ]
    The Standardized Assessment of Concussion and Symptom Severity Scale subscores of the SCAT3 will be done at every follow-up time point to assess cognitive functioning and symptom severity, respectively, as the patients' recovery progresses.

  3. Change in Quality of Life during Recovery as Measured with the Mayo-Portland Adaptability Inventory-4 (MPAI-4) [ Time Frame: Post-Injury Time Points of Data Collection: 3 months, and 1 year. ]
    The MPAI-4 is a standardized and comprehensive quality of life assessment that will be used to assess self-reported quality of life as the patients' recovery progresses.

  4. Change in Global Outcome during Recovery as Measured with the Glasgow Outcome Scale-Extended (GOS-E) [ Time Frame: Post-Injury Time Points of Data Collection: 3 months, 6 months, and 1 year. ]
    The GOS-E is commonly used in traumatic brain injury research to assess global changes in disability following traumatic brain injury as the patients' recovery progresses.

  5. Change in Memory Performance during Recovery as Measured with the Galveston Orientation and Amnesia Test (GOAT) [ Time Frame: Post-Injury Time Points of Data Collection: 3 months and 1 year. ]
    The GOAT is commonly used in traumatic brain injury research to assess global changes in memory performance following traumatic brain injury as the patients' recovery progresses.

  6. The Number of Prior Brain Injuries the Paitent has Suffered as Measured with the Boston Assessment of Traumatic Brain Injury-Lifetime [ Time Frame: Post-Injury Time Point of Data Collection: 2 weeks. ]
    This comprehensive and validated tool will allow for an accurate assessment of how many prior brain injuries a patient has had.

  7. Change in Cognitive Functioning during Recovery as Measured by the Brief Test of Adult Cognition by Telephone [ Time Frame: Post-Injury Time Points of Data Collection: 3 months and 1 year. ]
    This test of cognitive function will be used for those patients that are not able to come to the hospital for follow-up assessments.


Biospecimen Retention:   Samples With DNA
Blood draws will be taken for both proteomic and genetic analysis at acute and follow-up time points. The specimens will be used to test a specific set of biomarkers related to traumatic brain injury, and they will also be retained for future discovery efforts of novel biomarkers.


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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will include all trauma patients that present to the HCMC Emergency Department, trauma bay or as a direct transfer to neurosurgery.
Criteria

Inclusion Criteria:

  • All trauma patients that present to Hennepin County Medical Center.

Exclusion Criteria:

  • Age > 4 years old;
  • Major psychiatric or neurologic disorder: Active Psychotic Break, Trauma due to Suicide Attempt, Epilepsy, Multiple Sclerosis, Dementia, Guillain Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy, Significant Neurodegenerative Disorders, Muscular Dystrophy, and/or Malignant Intracranial Mass with Significant Mass Effect.
  • Developmentally Abnormal, or
  • Prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706574


Sponsors and Collaborators
Minneapolis Medical Research Foundation
Hennepin County Medical Center, Minneapolis
Abbott Diagnostics Division
Minnesota Office of Higher Education- SCI and TBI Research Grant Program
Investigators
Principal Investigator: Uzma Samadani, MD, PhD Physician, Neurosurgery

Publications:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02706574     History of Changes
Other Study ID Numbers: HSR 15-4079
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: July 2017

Keywords provided by Minneapolis Medical Research Foundation:
Eye Tracking
Blood-based Biomarkers
CSF-based Biomarkers
Magnetic Resonance Imaging
Computed Tomography Scan
Outcome Measures

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System