Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)

NCT ID: NCT03296592

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2025-12-30

Brief 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.

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.

Conditions

Cervical Spondylotic Myelopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI with DBSI technology

Intervention Type: DIAGNOSTIC_TEST

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

MRI with DBSI technology

Intervention Type: DIAGNOSTIC_TEST

The MRI will be done with diffusion basis spectrum imaging

Interventions

MRI with DBSI technology

The MRI will be done with diffusion basis spectrum imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Responsible Party

Wilson Z. Ray

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wilson Z Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

NS047592-10-201706177

Identifier Type: -

Identifier Source: org_study_id