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)
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.
Spinal cord injury (SCI) can result from trauma as well as degenerative conditions, such as
cervical spondylotic myelopathy (CSM). Both have a profound impact on the physical and
mental health of the affected individual. The symptoms of CSM can include weakness in the
arms or legs, difficulty with walking and balance, loss of dexterity in the hands, and bowel
or bladder dysfunction. Traumatic spinal cord injury often includes damage to white matter
tracts resulting in irreversible functional deficits such as paraplegia or quadriplegia.
Although current diagnostic imaging can reveal highly specific parameters of spinal canal
anatomy, the functional anatomy of the spinal cord remains unknown. Patients with similar
diagnostic findings can vary clinically with many patients having minimal to no symptoms
while others may be severely incapacitated. Conventional MRI methods, such as T1/T2 weighted
MRI, may easily identify the region of the damage and may depict permanent changes in the
spinal cord tissue. However, conventional MRI methods are limited in their ability to
correlate imaging findings with short and long term functional outcomes from spinal cord
injury. DTI has the potential to improve upon conventional MRI imaging by providing
information about tissue microstructure and may be particularly well suited for assessing
the integrity of fiber tracts in SCI.
Diffusion tensor magnetic resonance imaging (DTI) is a new technique that is highly
sensitive in detecting the integrity of white matter tracts. Although information obtained
from DTI has been utilized for white matter abnormalities in the brain, DTI of the spinal
cord in vivo has provided many challenges. The small size of the spinal cord and the close
packing of its white matter tracts require a very high image resolution to visualize these
individual tracts. The resolution required to image the small cross sectional area of the
spinal cord has been difficult to achieve using most widely used DTI sequences. To date, DTI
measurements reports have demonstrated a practical application of DTI on the cervical spinal
cord with limited spatial resolutions from 8 mm3 to 16 mm3.
To achieve high-resolution DTI of the spinal cord, two novel imaging techniques for
high-resolution in-vivo DTI on a clinical 3T MRI system (Trio, Siemens Medical Solution,
Erlangen Germany) have been developed: 2D singleshot Interleaved Multiple Inner Volume DWEPI
(ss-IMIV-DWEPI) and 3D singleshot DW STimulated EPI (3D ss-DWSTEPI). These optimized DTI
pulse sequences have typically achieved approximately 2.0 or 1.253 mm3 spatial resolution
within clinically achievable imaging time (~5 min.). The sequences have been designed
especially for high-resolution DTI of cervical spinal cord. They have been applied to spinal
cord specimens ex vivo as well as to a small group of healthy volunteers and multiple
sclerosis patients.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 |