Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)

NCT03296592 — Completed, 71 participants, Washington University School of Medicine

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Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy

Registry	NCT03296592, acronym CSM
Status	Completed
Study type	Observational
Enrollment	71 (Actual)
Sponsor	Washington University School of Medicine (Other); collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions	Cervical Spondylotic Myelopathy
Interventions	MRI with DBSI technology (Diagnostic test)
Dates	start 2018-01-29, primary completion 2024-03-30, completion 2025-12-29, first posted 2017-09-28, last updated 2026-03-17
Locations	1 site in United States

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Investigational subjects		Diagnostic Test: MRI with DBSI technology	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.
Control group		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

MRI with DBSI technology (Diagnostic test): The MRI will be done with diffusion basis spectrum imaging

+Outcome measures

Primary outcomes

Accurate prediction of neurologic outcomes after surgery [24 months]: Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.

Secondary outcomes

Assessment of effects of blood flow deficits on spinal cord pathology [24 months]: Outcome measure will assess effects of blood flow deficits on spinal cord pathology and determine the accuracy of axonal loss quantification in CSM

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* History of ongoing spinal cord compression,
* clinical evidence of CSM as determined by signs and symptoms including, but not limited to loss of manual dexterity, extremity weakness, sensory abnormalities, quadriparesis, loss of proprioception, and positive Babinski's or Hoffman's sign.

Exclusion Criteria:

* pregnant
* having an MRI incompatible device
* having a known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis, rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor or HIV-related myelopathy and having systemic instability or being deemed unable to tolerate standard MRI sequencing.

+Locations (1)

Facility	City	Country	Status
Washington University	St Louis, Missouri	United States

+Investigators

Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine

My Notes

Public

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