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

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ClinicalTrials.gov Identifier: NCT03296592
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Cervical Spondylotic Myelopathy 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 24 months later.


Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Assessment of effects of blood flow deficits on spinal cord pathology [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will enroll from our patient population and 20 patients from healthy volunteers.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296592


Contacts
Contact: Linda Koester, BS 3143627368 koesterl@wustl.edu
Contact: Aubrey Wright 3143623114 wrightau@wustl.edu

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Linda Koester, BS    314-362-7368    koesterl@wustl.edu   
Contact: Aubrey Wright    3143623114    wrightau@wustl.edu   
Principal Investigator: Wilson Z Ray, MD         
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03296592     History of Changes
Other Study ID Numbers: NS047592-10
2R01NS047592-10 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
myelopathy
diffusion MRI
spinal cord injury
spinal cord compression
spondylosis
cervical

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases