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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}, {'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accurate prediction of neurologic outcomes after surgery', 'timeFrame': '24 months', 'description': 'Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.'}], 'secondaryOutcomes': [{'measure': 'Assessment of effects of blood flow deficits on spinal cord pathology', 'timeFrame': '24 months', 'description': 'Outcome measure will assess effects of blood flow deficits on spinal cord pathology and determine the accuracy of axonal loss quantification in CSM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myelopathy', 'diffusion MRI', 'spinal cord injury', 'spinal cord compression', 'spondylosis', 'cervical'], 'conditions': ['Cervical Spondylotic Myelopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPatients 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.\n\nA control group of healthy volunteers will have an MRI using the DBSI technology when enrolled and then again between 12-24 months later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll from our patient population and 20 patients from healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of ongoing spinal cord compression,\n* 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.\n\nExclusion Criteria:\n\n* pregnant\n* having an MRI incompatible device\n* 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."}, 'identificationModule': {'nctId': 'NCT03296592', 'acronym': 'CSM', 'briefTitle': 'Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy', 'orgStudyIdInfo': {'id': 'NS047592-10-201706177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Investigational subjects', 'description': 'Patients who have been diagnosed with cervical spondylotic myelopathy and who will be undergoing surgical correction for this diagnosis.\n\nVisit 1 Investigational subjects will undergo a clinical assessment. Patients will undergo a DBSI MRI\n\nVisit 2. 6 months after surgery, investigational subjects will undergo a clinical assessment.\n\nVisit 3 12 months after surgery, investigational subjects will undergo a clinical assessment\n\nVisit 4 18 months after surgery, investigational subjects will undergo a clinical assessment.\n\nVisit 5 24 months after surgery, investigational subjects will undergo a clinical assessment and a DBSI MRI.', 'interventionNames': ['Diagnostic Test: MRI with DBSI technology']}, {'label': 'Control group', 'description': 'Healthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI', 'interventionNames': ['Diagnostic Test: MRI with DBSI technology']}], 'interventions': [{'name': 'MRI with DBSI technology', 'type': 'DIAGNOSTIC_TEST', 'description': 'The MRI will be done with diffusion basis spectrum imaging', 'armGroupLabels': ['Control group', 'Investigational subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Wilson Z Ray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wilson Z. Ray', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}