Diffusion MRI in Cervical Spondylotic Myelopathy (CSM) (CSM)

Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Spondylotic Myelopathy
• Intervention / Treatment: Diagnostic test: MRI with DBSI technology

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.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will enroll from our patient population and 20 patients from healthy volunteers.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Investigational subjects; 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; The MRI will be done with diffusion basis spectrum imaging
Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurate prediction of neurologic outcomes after surgery	Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: spinal cord injury; cervical; spinal cord compression; myelopathy; diffusion MRI; spondylosis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: NS047592-10-201706177; 2R01NS047592-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No