Traumatic Brain Injury Clinical Trial
Official title:
Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF
This hypothesis-generating feasibility study is being conducted to determine potential
associations between a broad range of clinical neurological symptoms and MR images, data,
and clinical findings involved in mild traumatic brain injury (mTBI). These associations
will be examined over the acute and sub-acute period (approximately 3 months) following
injury to provide information useful for optimization of MR pulse sequences for mTBI
applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers
detectable using investigational MR pulse sequence technologies. Feasibility data attained
in this study may be used for engineering program decision-making and in support of future
scientific assessment, engineering development, published research databases or registries
mTBI data and images, and other purposes determined by the Sponsor. The results of this
study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or
standard of care MR coils and a series of investigational Application Packs containing a
predetermined set of MR pulse sequences optimized by GEHC.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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