Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-06 @ 1:35 PM
Study NCT ID:
NCT03296592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSM
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: