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

The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Radiation: MRI

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 0513
      • Recruiting
      • Affiliated 2 Hospital of Nantong University
      • Principal Investigator: Hongqing Xu, Dr
      • Contact: Chunshuai Wu, Dr; Email: wcsspine@ntu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control, SCI-1, SCI-2, SCI-3; Control: No spinal cord injury	Radiation: MRI; Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.
SCI-1; SCI-1: spinal cord injury and ASIA Grade A and B	Radiation: MRI; Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.
SCI-2; SCI-2: spinal cord injury and ASIA Grade C	Radiation: MRI; Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.
SCI-3; SCI-3: spinal cord injury and ASIA Grade D	Radiation: MRI; Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 2016 to 2027
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.	From 2016 to 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years old, no need month nor day	From 2016 to 2027
Gender	male and female	From 2016 to 2027
Weight	In kilograms	From 2016 to 2027
Height	In meters	From 2016 to 2027
BMI	In kg/m^2	From 2016 to 2027

Collaborators and Investigators

• Sponsor: Affiliated 2 Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: WuCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No