Spinal Cord Injury Clinical Trial
Official title:
High-Resolution Diffusion Tensor Imaging (DTI) of the Cervical Spinal Cord in the Setting of Spinal Cord Injury (SCI)
Verified date | May 2014 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The investigators propose a prospective study, designed to analyze the efficacy of High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in subjects with spinal cord injury. Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
Status | Completed |
Enrollment | 31 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - For inclusion to the Cervical Spinal Cord (CSM) - Clinical and Radiographic evidence of cervical spondylotic myelopathy - 18 to 80 years of age - Safe and stable clinical scenario to undergo imaging - Awake, alert patient able to cooperate with physical examination - Give written informed consent prior to any testing under this protocol For inclusion to the Control Group, subject must have: - No diagnosis of cervical degenerative or traumatic disease - 30 to 80 years of age - Ability of volunteers to tolerate 1 hr examination For inclusion to the Degenerative Disease Group, subject must: - Have signs or symptoms consistent with spinal cord injury. - Be diagnosed with cervical spondylosis (degenerative disease). For inclusion to the Traumatic Group, subject must have: • A spinal cord injury associated with a traumatic event. Exclusion Criteria: - For exclusion to the Cervical Spinal Cord (CSM): - Unsafe or unstable clinical scenario - Prior cervical spine surgery - History of neurological disease (stroke, multiple sclerosis, peripheral neuropathy, or other neurodegenerative conditions) - Inability to comply with physical examination - Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..) - Pregnant women For exclusion to the other groups: - Inability to comply with physical examination - Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..) - Pregnant women |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Orthopedics | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | high-resolution DTI of cervical spinal cord | To determine the efficacy of high-resolution diffusion weighted pulse sequence with spatial resolution of 2.0 mm3 to confirm directionality and intactness of cervical spinal cord tracts in vivo in the setting of spinal cord injury and disease-free subjects. | 2 years | Yes |
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