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

Recruiting
Conditions
Spinal Cord Injuries
Interventions
Radiation: MRI
Registration Number
NCT06436716
Lead Sponsor
Affiliated 2 Hospital of Nantong University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
Inclusion Criteria
  1. MRI Diagnosis of TCSCI
  2. Clinic Diagnosis of TCSCI
  3. The injury site must be in cervical spinal cord
  4. MRI images of T2WI must be collected within 48 hours after injury
  5. Complete and available imaging data, clinical data, including MRI, sex, age
Exclusion Criteria
  1. Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
  2. The quality of MRI images is insufficient or there are serious motion artifacts

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
SCI-1MRISCI-1: spinal cord injury and ASIA Grade A and B
Control, SCI-1, SCI-2, SCI-3MRIControl: No spinal cord injury
SCI-2MRISCI-2: spinal cord injury and ASIA Grade C
SCI-3MRISCI-3: spinal cord injury and ASIA Grade D
Primary Outcome Measures
NameTimeMethod
MRI imageFrom 2016 to 2027

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.

ASIA scoresFrom 2016 to 2027

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.

Secondary Outcome Measures
NameTimeMethod
BMIFrom 2016 to 2027

In kg/m\^2

AgeFrom 2016 to 2027

Years old, no need month nor day

HeightFrom 2016 to 2027

In meters

GenderFrom 2016 to 2027

male and female

WeightFrom 2016 to 2027

In kilograms

Trial Locations

Locations (1)

Affiliated 2 Hospital of Nantong University

🇨🇳

Nantong, Jiangsu, China

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