Degenerative Cervical MyelopathyDCM-RBNCT07641699
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
An observational study of Degenerative Cervical Myelopathy and Non-myelopathic Degenerative Cervical Cord Compression, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression, Asymptomatic Degenerative Cervical Cord Compression
- What is being tested?
- Registry-based observation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2031
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102
Yin He, +8615901123675, milkywaymoon@163.com
Liguo Zhu
About this study
Official title: A Multicenter Registry-Based Study of Degenerative Cervical Myelopathy Across the Full Disease Spectrum Based on a Disease-Specific Registry Platform and Linked Biobank
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.
Read the detailed description
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.
- Conditions
- Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression, Asymptomatic Degenerative Cervical Cord Compression, Cervical Spinal Cord Compression
- Being tested
- Registry-based observation
- Keywords
- Degenerative cervical myelopathy, DCM, Non-myelopathic degenerative cervical cord compression, NMDCCC, Asymptomatic degenerative cervical cord compression, ADCC, Cervical spinal cord compression, Cervical spondylotic myelopathy, Patient registry, Biobank, Natural history, Disease progression, mJOA, Cervical MRI, Diffusion tensor imaging, T2 mapping, Blood biomarker, Traditional Chinese medicine syndrome
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry-based observationOther
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 group | Role | What they receive |
|---|---|---|
| A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy | Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression without clinical radiculopathy. Receives: Other: Registry-based observation | |
| A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy | Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression with clinical radiculopathy. Receives: Other: Registry-based observation | |
| B1: Mild Degenerative Cervical Myelopathy | Adults with clinically and radiologically confirmed degenerative cervical myelopathy with mild neurological impairment, defined as mJOA score 15-17. Receives: Other: Registry-based observation | |
| B2: Moderate Degenerative Cervical Myelopathy | Adults with clinically and radiologically confirmed degenerative cervical myelopathy with moderate neurological impairment, defined as mJOA score 12-14. Receives: Other: Registry-based observation | |
| B3: Severe Degenerative Cervical Myelopathy | Adults with clinically and radiologically confirmed degenerative cervical myelopathy with severe neurological impairment, defined as mJOA score 0-11. Receives: Other: Registry-based observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Cervical MyelopathyStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liguo Zhu, Study chair, Wangjing Hospital, China Academy of Chinese Medical SciencesHe Yin, Study director, Wangjing Hospital, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641699
- Sponsor's protocol ID
- 2024YFC3507401
- Acronym
- DCM-RB
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bednarik J, Kadanka Z, Dusek L, Novotny O, Surelova D, Urbanek I, Prokes B. Presymptomatic spondylotic cervical cord compression. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2260-9. doi: 10.1097/01.brs.0000142434.02579.84.
PubMed 15480138Yanez Touzet A, Bhatti A, Dohle E, Bhatti F, Lee KS, Furlan JC, Fehlings MG, Harrop JS, Zipser CM, Rodrigues-Pinto R, Milligan J, Sarewitz E, Curt A, Rahimi-Movaghar V, Aarabi B, Boerger TF, Tetreault L, Chen R, Guest JD, Kalsi-Ryan S, McNair AG, Kotter M, Davies B; AO Spine RECODE-DCM Steering Committee. Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM). BMJ Open. 2022 Jan 19;12(1):e057650. doi: 10.1136/bmjopen-2021-057650.
PubMed 35046007Davies BM, Yang X, Khan DZ, Mowforth OD, Touzet AY, Nouri A, Harrop JS, Aarabi B, Rahimi-Movaghar V, Kurpad SN, Guest JD, Tetreault L, Kwon BK, Boerger TF, Rodrigues-Pinto R, Furlan JC, Chen R, Zipser CM, Curt A, Milligan J, Kalsi-Rayn S, Sarewitz E, Sadler I, Blizzard T, Treanor C, Anderson D, Fallah N, Hazenbiller O, Salzman C, Zimmerman Z, Wandycz AM, Widdop S, Reeves M, Raine R, Ryan SK, Malone A, Gharooni A, Wilson JR, Martin AR, Fehlings MG, McNair AGK, Kotter MRN; AO SPINE RECODE-DCM Steering Committee and AO Spine RECODE DCM Community. A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study. PLoS Med. 2024 Aug 22;21(8):e1004447. doi: 10.1371/journal.pmed.1004447. eCollection 2024 Aug.
PubMed 39173109Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.
PubMed 29164035
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry-Based Study of Degenerative Cervical Myelopathy Across the Full Disease Spectrum Based on a Disease-Specific Registry Platform and Linked Biobank
- ClinicalTrials.gov ID
- NCT07641699
- Acronym / sponsor ID
- DCM-RB / 2024YFC3507401
- Conditions
- Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression, Asymptomatic Degenerative Cervical Cord Compression, Cervical Spinal Cord Compression
- Keywords
- Degenerative cervical myelopathy, DCM, Non-myelopathic degenerative cervical cord compression, NMDCCC, Asymptomatic degenerative cervical cord compression, ADCC, Cervical spinal cord compression, Cervical spondylotic myelopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Jun 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy | – | Other: Registry-based observationAdults with MRI-confirmed non-myelopathic degenerative cervical cord compression without clinical radiculopathy. |
| A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy | – | Other: Registry-based observationAdults with MRI-confirmed non-myelopathic degenerative cervical cord compression with clinical radiculopathy. |
| B1: Mild Degenerative Cervical Myelopathy | – | Other: Registry-based observationAdults with clinically and radiologically confirmed degenerative cervical myelopathy with mild neurological impairment, defined as mJOA score 15-17. |
| B2: Moderate Degenerative Cervical Myelopathy | – | Other: Registry-based observationAdults with clinically and radiologically confirmed degenerative cervical myelopathy with moderate neurological impairment, defined as mJOA score 12-14. |
| B3: Severe Degenerative Cervical Myelopathy | – | Other: Registry-based observationAdults with clinically and radiologically confirmed degenerative cervical myelopathy with severe neurological impairment, defined as mJOA score 0-11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Registry-based observationParticipants 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. | Other | A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy, A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy, B1: Mild Degenerative Cervical Myelopathy, B2: Moderate Degenerative Cervical Myelopathy, B3: Severe Degenerative Cervical Myelopathy |
Primary outcome
Time to First Composite Clinical Deterioration or Disease Progression Event
Time frame: 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.
8 secondary outcomes
Time to First Treatment Pathway Conversion
Time frame: Baseline to 36 months
Time to First Cervical Spine Surgery During Follow-up
Time frame: Baseline to 36 months
Time to First DCM-related Readmission
Time frame: Baseline to 36 months
Time to First Cervical Spine Reoperation or Additional Cervical Intervention
Time frame: Baseline to 36 months
Time to First Composite Major Functional Deterioration Event
Time frame: Baseline to 36 months
Percentage of Participants With Serious Adverse Events
Time frame: Baseline to 36 months
Percentage of Surgically Treated Participants With Surgical Adverse Events
Time frame: From surgery to 36 months after baseline
Percentage of Participants With All-Cause Mortality
Time frame: Baseline to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 15480138Bednarik J, Kadanka Z, Dusek L, Novotny O, Surelova D, Urbanek I, Prokes B. Presymptomatic spondylotic cervical cord compression. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2260-9. doi: 10.1097/01.brs.0000142434.02579.84.
- Results publication: PubMed 35046007Yanez Touzet A, Bhatti A, Dohle E, Bhatti F, Lee KS, Furlan JC, Fehlings MG, Harrop JS, Zipser CM, Rodrigues-Pinto R, Milligan J, Sarewitz E, Curt A, Rahimi-Movaghar V, Aarabi B, Boerger TF, Tetreault L, Chen R, Guest JD, Kalsi-Ryan S, McNair AG, Kotter M, Davies B; AO Spine RECODE-DCM Steering Committee. Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM). BMJ Open. 2022 Jan 19;12(1):e057650. doi: 10.1136/bmjopen-2021-057650.
- Results publication: PubMed 39173109Davies BM, Yang X, Khan DZ, Mowforth OD, Touzet AY, Nouri A, Harrop JS, Aarabi B, Rahimi-Movaghar V, Kurpad SN, Guest JD, Tetreault L, Kwon BK, Boerger TF, Rodrigues-Pinto R, Furlan JC, Chen R, Zipser CM, Curt A, Milligan J, Kalsi-Rayn S, Sarewitz E, Sadler I, Blizzard T, Treanor C, Anderson D, Fallah N, Hazenbiller O, Salzman C, Zimmerman Z, Wandycz AM, Widdop S, Reeves M, Raine R, Ryan SK, Malone A, Gharooni A, Wilson JR, Martin AR, Fehlings MG, McNair AGK, Kotter MRN; AO SPINE RECODE-DCM Steering Committee and AO Spine RECODE DCM Community. A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study. PLoS Med. 2024 Aug 22;21(8):e1004447. doi: 10.1371/journal.pmed.1004447. eCollection 2024 Aug.
- Results publication: PubMed 29164035Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.
- Individual participant dataSharing planned: 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.
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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.
Liguo Zhu study chair
Wangjing Hospital, China Academy of Chinese Medical Sciences
He Yin study director
Wangjing Hospital, China Academy of Chinese Medical Sciences
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 Degenerative Cervical Myelopathy and Non-myelopathic Degenerative Cervical Cord Compression, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 1 site in China.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Yin (+8615901123675, milkywaymoon@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Composite Clinical Deterioration or Disease Progression Event (time frame: Baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641699, which also lists 4 linked publications.
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 11 Jun 2026.