An observational study in Cervical Spondylotic Myelopathy, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Washington University School of Medicine · Observational
Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will have this MRI preoperatively and at 24 months postop. The investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. These patients will be compared to healthy cohorts who will also undergo an MRI using the DBSI technology.
CSM is the most common form of spinal cord injury and is the leading cause of progressive disability in patients over the age of 65. A major shortcoming limiting the clinical management of CSM is the lack of quantifiable metrics to 1) base clinical decisions and 2) predict potential for functional recovery following surgical intervention. DBSI MRI will provide imaging biomarkers to more reliably predict a patient's clinical course, response to therapy, and long-term prognosis.
Patients who are diagnosed with CSM will have an MRI using the DBSI technology preoperatively and at 24 months. Surgical patients will be assessed with the Neck Disability Index (NDI), Disability of the Arm, Shoulder and Hand (DASH), hand grip dynamometer and Manual Muscle Testing (MMT), the modified Japanese Orthopaedic Association scale (mJOA), and the Major Depression Inventory (MDI), the Short Form-36 (SF-36) and Nurick scoring.
A control group of healthy volunteers will have an MRI using the DBSI technology when enrolled and then again between 12-24 months later.
170 studies on the registry are indexed under Spinal Cord Diseases; 56 are open to participants now.
This study's enrollment of 71 is below the median of 100 across 45 observational studies indexed under Spinal Cord Diseases.
Browse Spinal Cord Diseases studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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We will enroll from our patient population and 20 patients from healthy volunteers.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have been diagnosed with cervical spondylotic myelopathy and who will be undergoing surgical correction for this diagnosis. Visit 1 Investigational subjects will undergo a clinical assessment. Patients will undergo a DBSI MRI Visit 2. 6 months after surgery, investigational subjects will undergo a clinical assessment. Visit 3 12 months after surgery, investigational subjects will undergo a clinical assessment Visit 4 18 months after surgery, investigational subjects will undergo a clinical assessment. Visit 5 24 months after surgery, investigational subjects will undergo a clinical assessment and a DBSI MRI.
Diagnostic Test: MRI with DBSI technology
Healthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI
Diagnostic Test: MRI with DBSI technology
The MRI will be done with diffusion basis spectrum imaging
Accurate prediction of neurologic outcomes after surgery
Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.
Time frame: 24 months
Assessment of effects of blood flow deficits on spinal cord pathology
Outcome measure will assess effects of blood flow deficits on spinal cord pathology and determine the accuracy of axonal loss quantification in CSM
Time frame: 24 months
Plan to share: No — The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Mar 2024, 74 months.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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