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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436716
• Other study ID #: WuCS
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Affiliated 2 Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
China	Affiliated 2 Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated 2 Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Age	Years old, no need month nor day	From 2016 to 2027
Secondary	Gender	male and female	From 2016 to 2027
Secondary	Weight	In kilograms	From 2016 to 2027
Secondary	Height	In meters	From 2016 to 2027
Secondary	BMI	In kg/m^2	From 2016 to 2027