Spinal Cord InjuryNCT04955509
A Scar Recognition Software for Chronic Spinal Cord Injury (SCI)
An observational study of Spinal Cord Injury, run by Peking University Third Hospital.
Trial summary
To construct and validate a software to recognize scar for patients with chronic SCI based on multimodal MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- MRI
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jun 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The patients came from the Peking University Third Hospital.
Who may be able to join
- (Prospective part) compliance to MRI scan
- (Prospective part) no MRI contraindication
- (Retrospective part) available conventional MRI data
- clinical diagnosis of SCI (the course of disease≥1 year)
Who cannot join
- prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, motor neuron disease, or spinal cord tumor
- images with motion artifact
Trial locations and contacts
No sites are listed yet.
Ouyang Hanqiang contact
About this study
Official title: In Vivo Optimization and Clinical Application of a Scar Recognition Software for Chronic Spinal Cord Injury (SCI)
To construct and validate a software to recognize scar for patients with chronic SCI based on multimodal MRI.
Read the detailed description
Spinal cord injury (SCI) is a kind of serious neurologic damage caused by violence to the spinal cord, resulting in various functions of the body below the injury level, including motor, sensory, sphincter, and reflex dysfunction in varying degrees, usually resulting in permanent and irreversible functional loss or paralysis of patients. The treatment of SCI is an essential problem in the world. In the past decades, experimental research on SCI involves genes, proteins, cells, and tissues, and has made great progress. However, these studies mainly focus on the SCI at the early stage, rather than the later stage. The reason is that in the later stage, scar formed by glial cells and fibroblasts in the injured area is a physical and chemical barrier, which inhibits the regeneration and myelination of nerve axons and results in inhibiting spinal cord repairment. Therefore, before the treatment of chronic SCI, the key problem is to distinguish glial scar tissue from normal tissue and eliminate its influence.
As glial scar inhibits axon regeneration, eliminating glial scar is necessary for the repair of the injured spinal cord. In recent years, a large number of experimental studies have been carried out to destroy the process of glial scar formation after SCI by enzyme digestion and antibody. Though these methods reduced glial scar, residual glial scars were reported in animal experiments. Compared to biochemical methods, surgical resection of glial scar tissue is a relatively simple and effective method to eliminate glial scars. Due to the limited regeneration ability of nerves after SCI, it is important to identify scar tissue accurately before operations to avoid surgical injury to normal tissue, which is also the premise of further research and clinical application of various interventional treatment methods.
Magnetic resonance imaging (MRI) is one of the most commonly used non-invasive imaging techniques to evaluate the degree of injury and therapeutic effect of SCI. Nemours MRI studies on SCI show the impact of SCI on the central nervous system from the structural and functional level and prove the potential application value of MRI in assisting doctors in the diagnosis of SCI. A small number of previous studies have used magnetization transfer imaging, and diffusion tensor imaging to detect glial scar tissue, showing the potential application value of these images in differentiation between glial scar and surrounding normal spinal cord. However, because glial cells, which constitute glial scar, are also important components of normal spinal cord tissue, previous studies only identified glial scar from a single aspect, such as tissue type, macromolecular component, or water molecular diffusion strength. Therefore, their specificities were unsatisfactory. Relative methods were unable to identify glial scar accurately and finally resulted in difficulty in treatment arrangement and evaluation of prognosis, which hinders the development of SCI treatment research.
Combing multimodal MRI, including conventional MRI and diffusion MRI, with supervised machine learning makes accurate glial identification in chronic SCI possible. multimodal MRI can depict the differences between scar tissue and non-scar tissue from the aspects of cell composition, water molecular dispersion, structural complexity, etc. Comparing to MRI with a single model, multimodal MRI provides more specific features. Machine learning, a way to construct robust and accurate models, can mine the quantitative relationship between imaging features and clinical diagnosis results, reveal MRI feature markers of the glial scar, to improve the accuracy of identification. The research work, combined with medicine, imaging, and artificial intelligence technology, is expected to solve the problem of accurate and non-invasive identification of glial scar in chronic SCI, which has potential application value for laboratory research and clinical treatment of chronic SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- MRI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
conventional MRI and diffusion MRI
| Study group | Role | What they receive |
|---|---|---|
| Training | random splitting based on random sequences generated by engineers to train and optimize a machine learning model Receives: Other: MRI | |
| Testing | random splitting based on random sequences generated by engineers to evaluate the performance of the model Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the fitted model
positive predictive value (PPV)
Measured: through study completion, an average of 2 year
Performance of the fitted model
sensitivity (SE)
Measured: through study completion, an average of 2 year
Performance of the fitted model
Dice coefficient score (DSC)
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955509
- Sponsor's protocol ID
- M2020400,M2020356
- Status last verified
- Sep 2020
- First submitted
- 29 Jun 2021
- Last updated
- 8 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Optimization and Clinical Application of a Scar Recognition Software for Chronic Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04955509
- Acronym / sponsor ID
- M2020400,M2020356
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 8 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.
To construct and validate a software to recognize scar for patients with chronic SCI based on multimodal MRI.
Detailed description
Spinal cord injury (SCI) is a kind of serious neurologic damage caused by violence to the spinal cord, resulting in various functions of the body below the injury level, including motor, sensory, sphincter, and reflex dysfunction in varying degrees, usually resulting in permanent and irreversible functional loss or paralysis of patients. The treatment of SCI is an essential problem in the world. In the past decades, experimental research on SCI involves genes, proteins, cells, and tissues, and has made great progress. However, these studies mainly focus on the SCI at the early stage, rather than the later stage. The reason is that in the later stage, scar formed by glial cells and fibroblasts in the injured area is a physical and chemical barrier, which inhibits the regeneration and myelination of nerve axons and results in inhibiting spinal cord repairment. Therefore, before the treatment of chronic SCI, the key problem is to distinguish glial scar tissue from normal tissue and eliminate its influence.
As glial scar inhibits axon regeneration, eliminating glial scar is necessary for the repair of the injured spinal cord. In recent years, a large number of experimental studies have been carried out to destroy the process of glial scar formation after SCI by enzyme digestion and antibody. Though these methods reduced glial scar, residual glial scars were reported in animal experiments. Compared to biochemical methods, surgical resection of glial scar tissue is a relatively simple and effective method to eliminate glial scars. Due to the limited regeneration ability of nerves after SCI, it is important to identify scar tissue accurately before operations to avoid surgical injury to normal tissue, which is also the premise of further research and clinical application of various interventional treatment methods.
Magnetic resonance imaging (MRI) is one of the most commonly used non-invasive imaging techniques to evaluate the degree of injury and therapeutic effect of SCI. Nemours MRI studies on SCI show the impact of SCI on the central nervous system from the structural and functional level and prove the potential application value of MRI in assisting doctors in the diagnosis of SCI. A small number of previous studies have used magnetization transfer imaging, and diffusion tensor imaging to detect glial scar tissue, showing the potential application value of these images in differentiation between glial scar and surrounding normal spinal cord. However, because glial cells, which constitute glial scar, are also important components of normal spinal cord tissue, previous studies only identified glial scar from a single aspect, such as tissue type, macromolecular component, or water molecular diffusion strength. Therefore, their specificities were unsatisfactory. Relative methods were unable to identify glial scar accurately and finally resulted in difficulty in treatment arrangement and evaluation of prognosis, which hinders the development of SCI treatment research.
Combing multimodal MRI, including conventional MRI and diffusion MRI, with supervised machine learning makes accurate glial identification in chronic SCI possible. multimodal MRI can depict the differences between scar tissue and non-scar tissue from the aspects of cell composition, water molecular dispersion, structural complexity, etc. Comparing to MRI with a single model, multimodal MRI provides more specific features. Machine learning, a way to construct robust and accurate models, can mine the quantitative relationship between imaging features and clinical diagnosis results, reveal MRI feature markers of the glial scar, to improve the accuracy of identification. The research work, combined with medicine, imaging, and artificial intelligence technology, is expected to solve the problem of accurate and non-invasive identification of glial scar in chronic SCI, which has potential application value for laboratory research and clinical treatment of chronic SCI.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | – | Other: MRIrandom splitting based on random sequences generated by engineers to train and optimize a machine learning model |
| Testing | – | Other: MRIrandom splitting based on random sequences generated by engineers to evaluate the performance of the model |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The patients came from the Peking University Third Hospital.
Key inclusion criteria (4 listed)
- (Prospective part) compliance to MRI scan
- (Prospective part) no MRI contraindication
- (Retrospective part) available conventional MRI data
- clinical diagnosis of SCI (the course of disease≥1 year)
Key exclusion criteria (2 listed)
- prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, motor neuron disease, or spinal cord tumor
- 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 |
|---|---|---|
| MRIconventional MRI and diffusion MRI | Other | Testing, Training |
Primary outcome
Performance of the fitted model
Time frame: through study completion, an average of 2 year
positive predictive value (PPV)
Performance of the fitted model
Time frame: through study completion, an average of 2 year
sensitivity (SE)
Performance of the fitted model
Time frame: through study completion, an average of 2 year
Dice coefficient score (DSC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Ouyang Hanqiang contact
Huishu Yuan principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Peking University Third Hospital.
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 4 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mengze Zhang (18600393607, zmzforever@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the fitted model (time frame: through study completion, an average of 2 year). The study lists 3 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 8 Jul 2021.