An observational study in Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression and Asymptomatic Degenerative Cervical Cord Compression, sponsored by Wangjing Hospital, China Academy of Chinese Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Wangjing Hospital, China Academy of Chinese Medical Sciences · Observational
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.
Degenerative cervical myelopathy (DCM) is an important cause of chronic spinal cord dysfunction in adults. The disease spectrum includes non-myelopathic degenerative cervical cord compression, which may occur with or without radiculopathy, and clinically established mild, moderate, or severe DCM. Current clinical management and research increasingly require standardized longitudinal data collection across different disease stages, treatment pathways, imaging phenotypes, and functional states.
This study will establish a multicenter, prospective, longitudinal, observational registry based on a disease-specific registry platform and linked biobank. The study itself will not interfere with clinical treatment decisions. Participants will receive routine clinical care under real-world practice, including observation, nonsurgical treatment, surgery, or follow-up after previous cervical spine surgery as clinically indicated.
All enrolled participants will enter the same registry platform and undergo standardized baseline assessment, scheduled follow-up, and event-driven supplemental data collection. The registry will use a two-level data structure consisting of a core dataset and optional extended datasets. The core dataset includes demographic characteristics, comorbidities, disease history, neurological examination, objective functional tests, mJOA, JOA, Nurick grade, Neck Disability Index, SF-36v2, cervical MRI findings, treatment exposure, treatment changes, hospitalization, surgery, readmission, reoperation, adverse events, and major functional events.
Extended datasets may include quantitative MRI, diffusion tensor imaging, T2 mapping, electrophysiology, standardized blood biomarkers, PBMC-based immune profiling, omics assays, optional surgically obtained tissue, and structured traditional Chinese medicine syndrome assessment, depending on center capability, ethical approval, funding, and assay validation. The recommended core MRI protocol includes conventional cervical MRI, DTI, and T2 mapping. The core blood collection protocol includes serum, EDTA plasma, buffy coat, and whole blood for biomarker assays and correction variables.
Scheduled follow-up visits are planned at baseline, 3 months, 6 months, 12 months, 24 months, and 36 months, with extension to 60 months when feasible. Event-driven supplemental data collection will be performed when participants develop new myelopathic signs, clinically meaningful neurological deterioration, treatment escalation, surgery, readmission, reoperation, or other major functional events.
The primary endpoint is a composite endpoint of clinical deterioration or disease progression across the spectrum of degenerative cervical cord compression and DCM. The registry will support natural history research, clinical trajectory analysis, treatment pathway evaluation, biomarker exploration, nested prognostic modeling, and real-world outcome evaluation.
402 studies on the registry are indexed under Disease Progression; 112 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 213 observational studies indexed under Disease Progression.
Browse Disease Progression studies →Wangjing Hospital, China Academy of Chinese Medical Sciences is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with MRI-confirmed degenerative cervical spinal cord compression caused by degenerative pathology will be enrolled from spine outpatient clinics, inpatient wards, preoperative assessment pathways, postoperative follow-up, and imaging review pathways. The study population includes non-myelopathic degenerative cervical cord compression, with or without radiculopathy, and clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy. All participants must be able to complete baseline core assessments, provide written informed consent, and participate in longitudinal follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression without clinical radiculopathy.
Other: Registry-based observation
Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression with clinical radiculopathy.
Other: Registry-based observation
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with mild neurological impairment, defined as mJOA score 15-17.
Other: Registry-based observation
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with moderate neurological impairment, defined as mJOA score 12-14.
Other: Registry-based observation
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with severe neurological impairment, defined as mJOA score 0-11.
Other: 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.
Time to First Composite Clinical Deterioration or Disease Progression Event
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.
Time frame: Baseline to 36 months
Time to First Treatment Pathway Conversion
This outcome will be reported as the time from baseline to the first treatment pathway conversion. Treatment pathway conversion is defined as a change from observation or regular follow-up to nonsurgical treatment, from observation or nonsurgical treatment to surgery, or another clinically justified treatment strategy change due to symptom worsening, neurological deterioration, imaging progression, or other objective disease progression. Participants without treatment pathway conversion will be censored at the last available follow-up. The unit of measure is months from baseline to first treatment pathway conversion.
Time frame: Baseline to 36 months
Time to First Cervical Spine Surgery During Follow-up
This outcome will be reported as the time from baseline to the first cervical spine surgery related to degenerative cervical cord compression or degenerative cervical myelopathy during follow-up. Cervical spine surgery includes cervical decompression, fusion, laminoplasty, or other DCM-related cervical surgical procedures. Participants without cervical spine surgery will be censored at the last available follow-up. The unit of measure is months from baseline to first cervical spine surgery.
Time frame: Baseline to 36 months
Time to First DCM-related Readmission
This outcome will be reported as the time from baseline to the first readmission related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, symptom aggravation, or other cervical spine-related causes. Participants without DCM-related readmission will be censored at the last available follow-up. The unit of measure is months from baseline to first DCM-related readmission.
Time frame: Baseline to 36 months
Time to First Cervical Spine Reoperation or Additional Cervical Intervention
This outcome will be reported as the time from baseline to the first cervical spine reoperation or additional cervical intervention related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, adjacent segment problems, or other cervical spine-related causes. Participants without reoperation or additional cervical intervention will be censored at the last available follow-up. The unit of measure is months from baseline to first reoperation or additional cervical intervention.
Time frame: Baseline to 36 months
Time to First Composite Major Functional Deterioration Event
This outcome will be reported as the time from baseline to the first occurrence of any component of the predefined composite major functional deterioration endpoint. The composite endpoint is considered to have occurred when a participant first experiences new or obviously worsened sphincter dysfunction, loss of independent ambulation, serious fall-related consequences, marked decline in activities of daily living, or another clinically meaningful major functional deterioration 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 first composite major functional deterioration event.
Time frame: Baseline to 36 months
Percentage of Participants With Serious Adverse Events
This outcome will be reported as the percentage of participants who experience at least one serious adverse event during follow-up. Serious adverse events include events resulting in death, life-threatening events, hospitalization or prolonged hospitalization, persistent or significant disability, or other medically important events. The unit of measure is the percentage of participants.
Time frame: Baseline to 36 months
Percentage of Surgically Treated Participants With Surgical Adverse Events
This outcome will be reported as the percentage of surgically treated participants who experience at least one surgical adverse event. Surgical adverse events may be recorded using SAVES-V2 or an equivalent structured adverse event recording tool when feasible. The unit of measure is percentage of surgically treated participants.
Time frame: From surgery to 36 months after baseline
Percentage of Participants With All-Cause Mortality
This outcome will be reported as the percentage of participants who die from any cause during follow-up. The date of death and main cause of death will be recorded when available. The unit of measure is the percentage of participants.
Time frame: Baseline to 36 months
Change From Baseline in mJOA Score
This outcome will be reported as the change from baseline in the modified Japanese Orthopaedic Association score at each scheduled follow-up visit. The mJOA score is a clinician-administered neurological function scale for degenerative cervical myelopathy. The unit of measure is points on the mJOA scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in JOA Score
This outcome will be reported as the change from baseline in the Japanese Orthopaedic Association score at each scheduled follow-up visit. The unit of measure is points on the JOA scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Nurick Grade
This outcome will be reported as the change from baseline in Nurick grade at each scheduled follow-up visit. The Nurick grade is an ordinal clinician-rated measure of gait-related functional impairment in cervical myelopathy. The unit of measure is grade on the Nurick scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Neck Disability Index Score
This outcome will be reported as the change from baseline in the Neck Disability Index score at each scheduled follow-up visit. The Neck Disability Index is a patient-reported questionnaire assessing neck-related disability. The unit of measure is points on the Neck Disability Index scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in SF-36v2 Physical Component Summary Score
This outcome will be reported as the change from baseline in the SF-36v2 Physical Component Summary score at each scheduled follow-up visit. The SF-36v2 is a patient-reported health-related quality of life questionnaire. The unit of measure is points on the SF-36v2 Physical Component Summary scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in SF-36v2 Mental Component Summary Score
This outcome will be reported as the change from baseline in the SF-36v2 Mental Component Summary score at each scheduled follow-up visit. The SF-36v2 is a patient-reported health-related quality of life questionnaire. The unit of measure is points on the SF-36v2 Mental Component Summary scale.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in 10-Second Grip-and-Release Test Count
This outcome will be reported as the change from baseline in the number of grip-and-release cycles completed within 10 seconds at each scheduled follow-up visit. The 10-second grip-and-release test is an objective hand function test. The unit of measure is the number of cycles.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in 10-Meter Walking Speed
This outcome will be reported as the change from baseline in walking speed measured by the 10-meter walking test at each scheduled follow-up visit. The unit of measure is meters per second.
Time frame: Baseline, 12 months, 24 months, and 36 months, or according to clinical follow-up availability
Change From Baseline in Maximum Spinal Cord Compression
This outcome will be reported as the change from baseline in maximum spinal cord compression measured on cervical MRI. Maximum spinal cord compression will be assessed using offline quantitative MRI measurement. The unit of measure is percentage.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Maximum Canal Compromise
This outcome will be reported as the change from baseline in maximum canal compromise measured on cervical MRI. Maximum canal compromise will be assessed using offline quantitative MRI measurement. The unit of measure is percentage.
Time frame: Baseline, 12 months, 24 months, and 36 months
Change From Baseline in Spinal Cord Cross-Sectional Area
This outcome will be reported as the change from baseline in spinal cord cross-sectional area measured on cervical MRI at the target compression level. The unit of measure is square millimeters.
Time frame: Baseline, 12 months, 24 months, and 36 months, when available
Change From Baseline in DTI Fractional Anisotropy
This outcome will be reported as the change from baseline in fractional anisotropy measured by cervical spinal cord diffusion tensor imaging at the target level or predefined region of interest. The unit of measure is fractional anisotropy value.
Time frame: Baseline, 12 months, 24 months, and 36 months
Change From Baseline in T2 Mapping Value
This outcome will be reported as the change from baseline in cervical spinal cord T2 mapping value measured at the target level or predefined region of interest. The unit of measure is milliseconds.
Time frame: Baseline, 12 months, 24 months, and 36 months
Change From Baseline in Plasma Neurofilament Light Chain Concentration
This outcome will be reported as the change from baseline in plasma neurofilament light chain concentration measured in EDTA plasma. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Serum Interleukin-6 Concentration
This outcome will be reported as the change from baseline in serum interleukin-6 concentration measured in serum. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Plasma Brain-Derived Neurotrophic Factor Concentration
This outcome will be reported as the change from baseline in plasma brain-derived neurotrophic factor concentration measured in EDTA plasma. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months
Time to First Worsening in Symptom and Functional State Category
This outcome will be reported as the time from baseline to the first worsening in the predefined symptom and functional state category. Symptom and functional state will be classified by investigators using a predefined ordinal state category: S0, imaging compression without definite symptoms or signs; S1, radiculopathy-dominant state; S2, sensory-dominant state; S3, upper-limb motor or hand-function dominant state; S4, lower-limb or gait-dominant state; S5, mixed motor involvement; and S6, sphincter dysfunction or severe functional impairment. "Worsening" is defined as a transition to a higher severity state category. The unit of measure is months from baseline to the first worsening in the state category.
Time frame: Baseline to 36 months
Plan to share: Undecided — The individual participant data sharing plan has not yet been finalized. De-identified data may be made available for ethically approved collaborative research after completion of the main analyses, subject to institutional policies, ethics approval, data use agreements, and applicable regulations. Biospecimen access and transfer will require additional approval according to the biobank governance policy, ethics approval, sample management standard operating procedures, and material transfer agreements.
Start is estimated for Jun 2026; primary completion for Dec 2031, 66 months later.
Of 103 non-industry observational studies under Disease Progression, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 153. This study's planned 66 months is close to that.
Counting every sponsor, half of 108 studies reached it within 68 months; a quarter within 35 and three quarters within 153.
Disease Progression covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Wangjing Hospital, China Academy of Chinese Medical Sciences