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Observational
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Condition(s) studied
Degenerative Cervical MyelopathyNon-myelopathic Degenerative Cervical Cord CompressionAsymptomatic Degenerative Cervical Cord CompressionCervical Spinal Cord Compression
Investigational drug(s) / intervention(s)
Registry-based observation
Registry-based observation: Participants will receive routine clinical care according to real-world clinical decision-making. The study does not assign or mandate surgical or nonsurgical treatment. Clinical data, imaging data, follow-up outcomes, adverse events, and biospecimens will be collected according to the registry protocol.
Study summary
This is a multicenter, prospective, longitudinal, observational registry-based study of degenerative cervical myelopathy (DCM) across the full disease spectrum, linked to a disease-specific biobank. The study will enroll adults with non-myelopathic degenerative cervical cord compression, including asymptomatic degenerative cervical cord compression with or without radiculopathy, as well as patients with mild, moderate, or severe DCM. The study does not assign treatment or interfere with real-world clinical decision-making. All participants will undergo standardized baseline assessment, scheduled follow-up, and event-driven supplemental data collection. Core data include demographic information, comorbidities, disease characteristics, neurological examination, objective functional tests, patient-reported outcomes, cervical MRI findings, treatment pathway, treatment changes, adverse events, and long-term clinical outcomes. In participating centers, standardized biospecimen collection will be performed to support nested biomarker, immune, imaging, electrophysiological, and traditional Chinese medicine syndrome substudies. The main objective is to establish a standardized multicenter registry platform covering non-myelopathic degenerative cervical cord compression and mild, moderate, and severe DCM; to describe clinical trajectories, imaging evolution, treatment pathways, and long-term outcomes; and to identify factors associated with disease deterioration and functional prognosis.
Eligibility
Inclusion Criteria:
* Age 18 years or older.
* Cervical MRI confirms cervical spinal cord compression caused by degenerative pathology, including but not limited to disc protrusion or bulging, osteophyte formation, ligamentum flavum hypertrophy or ossification, ossification of the posterior longitudinal ligament, degenerative cervical canal stenosis, or other degenerative compressive factors.
* At least one cervical level meets one or more of the following imaging criteria: partial or complete disappearance of the cerebrospinal fluid space around the spinal cord, direct contact between the spinal cord and degenerative compressive structures, focal spinal cord indentation, flattening or deformation, or other recognized imaging manifestations of degenerative cervical cord compression.
* Meets one of the following clinical phenotypes: non-myelopathic degenerative cervical cord compression, with or without clinical radiculopathy; or clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy.
* Able to complete baseline core assessments and willing to participate in longitudinal follow-up.
* Provides written informed consent. Additional consent may be obtained for specific biospecimen types or nested substudies.
Exclusion Criteria:
* Cervical spinal cord compression or myelopathy mainly caused by non-degenerative etiologies, such as acute trauma, tumor, infection, inflammatory or demyelinating disease, vascular lesion, obvious congenital malformation, or other non-degenerative spinal cord disease.
* Presence of a dominant other neurological disease or severe psychiatric or cognitive disorder that, in the investigator's judgment, would clearly interfere with DCM-related neurological functional assessment or make reliable follow-up impossible.
* Objective inability to complete the core imaging assessment or core follow-up and judged by the investigator to be unsuitable for inclusion in the main registry cohort.
* Refusal to sign informed consent or explicit refusal of core data collection and follow-up.
Primary outcome measure(s)
- Time to First Composite Clinical Deterioration or Disease Progression Event — Baseline to 36 months
This outcome will be reported as the time from baseline to the first occurrence of any component of the predefined composite clinical deterioration or disease progression endpoint. The composite endpoint is considered to have occurred when a participant first experiences one or more of the following events: progression from non-myelopathic degenerative cervical cord compression to clinical degenerative cervical myelopathy, a decrease in mJOA score of at least 2 points from baseline; a new clinically meaningful neurological deficit or definite myelopathic sign; predefined worsening in symptom/function state; treatment escalation due to objective disease progression; new sphincter dysfunction; loss of independent ambulation; or another major functional event adjudicated by investigators. Participants without any component event will be censored at the last available follow-up. The unit of measure is months from baseline to the first composite event.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Wangjing Hospital, China Academy of Chinese Medical Sciences |
Beijing |
Beijing Municipality |
|
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