Analysis Techniques for Diffusion Tensor Imaging in Spinal Cord Disease

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AG034732-01A1
Agency Tracking Number: AG034732
Amount: $361,325.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NIA
Solicitation Number: PHS2010-2
Small Business Information
PRISM CLINICAL IMAGING, INC., 890 Elm Grove Rd. Ste. 215, Elm Grove, WI, 53122
DUNS: 190899638
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (262) 754-3840
Business Contact
Phone: (262) 754-3840
Research Institution
DESCRIPTION (provided by applicant): Myelopathy secondary to cervical spondylosis is a common cause of disability, and the most common primary diagnosis for patients over 64 years who undergo cervical spine surgery. Some studies suggest that surgical intervention after neurological decline is associated with worse outcome, prompting surgeons to operate earlier on the basis of imaging even in the absence of clinical symptoms, even though the predictive value of currently available imaging technology is poor. Because of the lack of accuracy in both clinical and radiographic prediction for disease progression, many patients who undergo surgery do not show significant improvement. Magnetic resonance imaging (MRI) is the gold standard to visualize the cervical spine, but clinical studies have not shown consistent correlation between T1- and T2-weighted MRI findings with patient outcome after either surgical or medical treatment. Diffusion tensor imaging (DTI) has a significant advantage over routine MRI in showing changes in white matter structural integrity in the spinal cord. Technical challenges remain in clinical translation of spinal DTI, including correction of distortion related to bone proximity, and cerebrospinal fluid (CSF) movement. There is an unmet need for multi-parameter, multi-modality spinal imaging visualization tools suited to the clinical workflow. We will design and implement a spinal imaging tool based upon our FDA-cleared Prism View(R) software package, currently indicated for use in pre- treatment planning for brain disorders. We will demonstrate feasibility in Phase I by developing means for visualizing pre- and post-treatment spinal imaging including anatomical, color-coded DTI mapping, quantitative diffusion parameter measurement, and functional mapping of diffusion spinal tractography. In Phase II, we will pursue clinical validation of spinal diffusion imaging by including spinal somatosensory evoked potential (SpSEP) studies, expand imaging to include registration of spinal CT, and investigate the utility of spinal tractography in surgical interventions such as stem cell implantation. Our initial focus is on applications to myelopathy, but it is expected that the technology will also find application in radiculopathy and spinal cord injury assessment, treatment planning, and follow-up. PUBLIC HEALTH RELEVANCE: We will develop and evaluate imaging tools to aid in the diagnosis, treatment planning, and follow-up of cervical myelopathy, a common cause of disability subject to surgical intervention. This will include application of diffusion tensor imaging (DTI) to assess white matter integrity and provide functional mapping of the spinal cord with potential applications to tract-wise treatment methods.

* information listed above is at the time of submission.

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