This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
477
MRI scanning
University of California-San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Universtiy of Miami Health System
Miami, Florida, United States
Hospital for Special Surgery
New York, New York, United States
MRI Image Data Sets
MRI image data sets collected from subjects who completed the study.
Time frame: Per patient scanning over 3 months
Neuropsychological Assessments
Neuropsychological assessments collected from subjects who completed the study.
Time frame: Per patient scanning over 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pittsburgh Medical College
Pittsburgh, Pennsylvania, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States