Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAffiliated 2 Hospital of Nantong University

About this trial

Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

MRI Diagnosis of TCSCI

Clinic Diagnosis of TCSCI

The injury site must be in cervical spinal cord

MRI images of T2WI must be collected within 48 hours after injury

Disqualifiers

Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord

The quality of MRI images is insufficient or there are serious motion artifacts

Trial population

MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • MRI

    Radiation

    Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Control, SCI-1, SCI-2, SCI-31 intervention
Group B: SCI-11 intervention
Group C: SCI-21 intervention
Group D: SCI-31 intervention

Trial outcomes

Primary outcomes

1

MRI image

original MRI image format DICOM to Nii was based on Python (Version: 3.10.6), and those would be loaded into the MRIcroGMRI imageL software (Version: 12.2). Three spinal surgeons (with 5, 8 and 18 years of experience in interpreting spinal MRI respectively) manually depict the region of interest (ROI) of the lesion area layer by layer, to form three dimensional (3D) volume of interest (VOI). After the primary spinal surgeon finished depicting the injured spinal cord, the senior spinal surgeon checked the quality of ROI and made some adjustments.

Time frame
From 2016 to 2027
2

ASIA scores

ASIA scores means American Spinal Injury Association Impairment Scale. ASIA has 5 grades depends on the severity of spinal cord injury. Grade A :No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing. Grade B:Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body. Grade C: Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2). Grade D: Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3. Grade E: If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits.

Time frame
From 2016 to 2027

Secondary outcomes

1

Age

Years old, no need month nor day

Time frame
From 2016 to 2027
2

Gender

male and female

Time frame
From 2016 to 2027
3

Weight

In kilograms

Time frame
From 2016 to 2027
4

Height

In meters

Time frame
From 2016 to 2027

Other outcomes

Sponsors and contacts

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