Cervical Spondylotic MyelopathyNCT04952831
Diffusion MRI in Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylotic Myelopathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
diffusion MRI in evaluates and predicts prognosis in CSM Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- diffusion MRI (dMRI)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2024
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients come from the Peking University Third Hospital. Healthy volunteers come from online recruitment.
Who may be able to join
- ages ranged 30-75
- compliance to MRI scan
- no MRI contraindication
- (Patients) clinical diagnosis of CSM and surgery in our hospital
- (Healthy controls) no spinal cord dysfunction
Who cannot join
- prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, spinal cord injury, motor neuron disease, or spinal cord tumour
- images with motion artifact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of Diffusion Magnetic Resonance Imaging (dMRI) in Evaluation of Spinal Cord Dysfunction and Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)
diffusion MRI in evaluates and predicts prognosis in CSM
Read the detailed description
Cervical spondylotic myelopathy (CSM) is a spinal dysfunction disease common in the elderly population caused by cervical spine degeneration, spinal canal stenosis, and spinal cord compression. It may result in reduced quality of life or even disability. With the increased life expectancy of today's population, the incidence of CSM is increasing. Surgery is recommended to reduce compression of the spinal cord. However, due to individual differences and variations in spinal cord injury severity, the prognosis after surgery is often unpredictable. Therefore, proper evaluation of spinal cord function and prognosis prediction are important considerations for the clinical decision of whether to operate and selection of appropriate operation time. To achieve this goal, medical images are used to correctly evaluate the damage and recovery potential of neurons. Magnetic resonance imaging (MRI) provides spinal cord macrostructure details and can detect spinal cord damage. Clinically, conventional MRI is often used to confirm a CSM diagnosis and predict prognosis. However, MRI assessments, including increased signal intensity (ISI) and T1 hypo-intensity, might not be consistent with clinical manifestations or prognostic expectations.
Diffusion MRI (dMRI) enables early diagnoses and prognostic predictions due to its microstructure assessment advantages. The diffusion of water molecules is restricted due to structural barriers, such as axon membranes and myelin sheaths. Using the microscopic movement of water molecules, dMRI can detect microstructures indirectly using a model with specific underlying probability distribution function of diffusion. Three models are widely applied clinically: diffusion tensor imaging (DTI), diffusional kurtosis imaging (DKI), and neurite orientation dispersion and density imaging (NODDI). DTI assumes the diffusion distribution function to be Gaussian, DKI assumes it to be non-Gaussian, and NODDI assumes it to be multi-compartmental (intracellular pool, extracellular pool, and free water). Previous studies suggested the potential application value of DTI and DKI in patients with CSM; however, these models had limited specificity and were not sufficient to diagnose CSM in a clinical setting. Compared with DTI and DKI, NODDI has been shown to characterize spinal cord microstructure better.
- Conditions
- Cervical Spondylotic Myelopathy
- Being tested
- diffusion MRI (dMRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion MRI (dMRI)Other
All participants underwent dMRI scan at baseline
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild CSM | mJOA score ≥15 Receives: Other: diffusion MRI (dMRI) | |
| Patients with moderate CSM | mJOA score 13~14 Receives: Other: diffusion MRI (dMRI) | |
| Patients with severe CSM | mJOA score ≤ 12 Receives: Other: diffusion MRI (dMRI) | |
| Controls | health volunteers Receives: Other: diffusion MRI (dMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative neurologic improvement
Postoperative modified Japanese Orthopaedic Association (mJOA) and recovery rate (RR) at 3-month, 6-month, 12-month, and 24-month for patients
Measured: 3-month, 6-month, 12-month, and 24-month
diagnosis of CSM
whether participants are diagnosed as CSM at baseline.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2024 (estimated)
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Dr, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952831
- Sponsor's protocol ID
- M2020408
- Status last verified
- Sep 2020
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Diffusion Magnetic Resonance Imaging (dMRI) in Evaluation of Spinal Cord Dysfunction and Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)
- ClinicalTrials.gov ID
- NCT04952831
- Acronym / sponsor ID
- M2020408
- Conditions
- Cervical Spondylotic Myelopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 Jul 2021 (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.
diffusion MRI in evaluates and predicts prognosis in CSM
Detailed description
Cervical spondylotic myelopathy (CSM) is a spinal dysfunction disease common in the elderly population caused by cervical spine degeneration, spinal canal stenosis, and spinal cord compression. It may result in reduced quality of life or even disability. With the increased life expectancy of today's population, the incidence of CSM is increasing. Surgery is recommended to reduce compression of the spinal cord. However, due to individual differences and variations in spinal cord injury severity, the prognosis after surgery is often unpredictable. Therefore, proper evaluation of spinal cord function and prognosis prediction are important considerations for the clinical decision of whether to operate and selection of appropriate operation time. To achieve this goal, medical images are used to correctly evaluate the damage and recovery potential of neurons. Magnetic resonance imaging (MRI) provides spinal cord macrostructure details and can detect spinal cord damage. Clinically, conventional MRI is often used to confirm a CSM diagnosis and predict prognosis. However, MRI assessments, including increased signal intensity (ISI) and T1 hypo-intensity, might not be consistent with clinical manifestations or prognostic expectations.
Diffusion MRI (dMRI) enables early diagnoses and prognostic predictions due to its microstructure assessment advantages. The diffusion of water molecules is restricted due to structural barriers, such as axon membranes and myelin sheaths. Using the microscopic movement of water molecules, dMRI can detect microstructures indirectly using a model with specific underlying probability distribution function of diffusion. Three models are widely applied clinically: diffusion tensor imaging (DTI), diffusional kurtosis imaging (DKI), and neurite orientation dispersion and density imaging (NODDI). DTI assumes the diffusion distribution function to be Gaussian, DKI assumes it to be non-Gaussian, and NODDI assumes it to be multi-compartmental (intracellular pool, extracellular pool, and free water). Previous studies suggested the potential application value of DTI and DKI in patients with CSM; however, these models had limited specificity and were not sufficient to diagnose CSM in a clinical setting. Compared with DTI and DKI, NODDI has been shown to characterize spinal cord microstructure better.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with mild CSM | – | Other: diffusion MRI (dMRI)mJOA score ≥15 |
| Patients with moderate CSM | – | Other: diffusion MRI (dMRI)mJOA score 13~14 |
| Patients with severe CSM | – | Other: diffusion MRI (dMRI)mJOA score ≤ 12 |
| Controls | – | Other: diffusion MRI (dMRI)health volunteers |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients come from the Peking University Third Hospital. Healthy volunteers come from online recruitment.
Key inclusion criteria (5 listed)
- ages ranged 30-75
- compliance to MRI scan
- no MRI contraindication
- (Patients) clinical diagnosis of CSM and surgery in our hospital
- (Healthy controls) no spinal cord dysfunction
Key exclusion criteria (2 listed)
- prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, spinal cord injury, motor neuron disease, or spinal cord tumour
- images with motion artifact
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 |
|---|---|---|
| diffusion MRI (dMRI)All participants underwent dMRI scan at baseline | Other | Controls, Patients with mild CSM, Patients with moderate CSM, Patients with severe CSM |
Primary outcome
Postoperative neurologic improvement
Time frame: 3-month, 6-month, 12-month, and 24-month
Postoperative modified Japanese Orthopaedic Association (mJOA) and recovery rate (RR) at 3-month, 6-month, 12-month, and 24-month for patients
diagnosis of CSM
Time frame: at baseline
whether participants are diagnosed as CSM at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Huishu Yuan, Dr principal investigator
Peking University Third Hospital
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 Peking University Third Hospital 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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?
Results are not available in the source record.
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?
Postoperative neurologic improvement (time frame: 3-month, 6-month, 12-month, and 24-month). The study lists 2 primary outcomes in all. 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 7 Jul 2021.