Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)

NCT03296592 | Completed

• 1 other identifier: NS047592-10-201706177
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylotic Myelopathy

Keywords

myelopathy; diffusion MRI; spinal cord injury; spinal cord compression; spondylosis; cervical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of effects of blood flow deficits on spinal cord pathology

  24 months

Study Arms (2)

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

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

Interventions

MRI with DBSI technology DIAGNOSTIC_TEST

The MRI will be done with diffusion basis spectrum imaging

Control group; Investigational subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression; Spondylosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wilson Z Ray, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: January 29, 2018
• Primary Completion: March 30, 2024
• Study Completion: December 29, 2025
• Last Updated: March 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)