Advanced MRI Applications for Mild Traumatic Brain Injury (TBI)
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), 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.
Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Advanced MRI Applications for Mild Traumatic Brain Injury|
- mTBI progression indicated by clinical neurological characteristics, MRI images, and quantitative MRI data from novel software [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).
- Subject demographics [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.
- Operator set MRI parameters [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]To record operator-adjusted parameters of the novel software on the MRI system
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02070588
|Contact: Teena Shetty, MD||+1 firstname.lastname@example.org|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 08540|
|Principal Investigator: Teena Shetty, MD|