Cervical Spondylotic MyelopathyCSMNCT03296592
Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)
An observational study of Cervical Spondylotic Myelopathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- MRI with DBSI technology
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 29 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll from our patient population and 20 patients from healthy volunteers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- MRI with DBSI technology
- Keywords
- myelopathy, diffusion MRI, spinal cord injury, spinal cord compression, spondylosis, cervical
- Medical subject headings
- Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with DBSI technologyDiagnostic test
The MRI will be done with diffusion basis spectrum imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Diagnostic Test: MRI with DBSI technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate prediction of neurologic outcomes after surgery
Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.
Measured: 24 months
Secondary outcomes (1)
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start29 Jan 2018
- Primary completion30 Mar 2024
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic MyelopathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Wilson Z. Ray, Washington University School of Medicine
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296592
- Sponsor's protocol ID
- NS047592-10-201706177
- Acronym
- CSM
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2017
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy
- ClinicalTrials.gov ID
- NCT03296592
- Acronym / sponsor ID
- CSM / NS047592-10-201706177
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- myelopathy, diffusion MRI, spinal cord injury, spinal cord compression, spondylosis, cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational subjects | – | Diagnostic Test: MRI with DBSI technologyPatients 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. |
| Control group | – | Diagnostic Test: MRI with DBSI technologyHealthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll from our patient population and 20 patients from healthy volunteers.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI with DBSI technologyThe MRI will be done with diffusion basis spectrum imaging | Diagnostic test | Control group, Investigational subjects |
Primary outcome
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.
1 secondary outcome
Assessment of effects of blood flow deficits on spinal cord pathology
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.
Related trials for Cervical Spondylotic Myelopathy
Not yet recruitingObservational study
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Not yet recruiting
Efficacy of Two Approaches in Cervical Single-door Laminoplasty for Spinal Canal Enlargement
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Recruiting
Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy
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Enrolling by invitationObservational study
Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson Z Ray, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylotic Myelopathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate prediction of neurologic outcomes after surgery (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.