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

NCT06436716 | Recruiting

• 1 other identifier: WuCS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Age

  From 2016 to 2027

• Gender

  From 2016 to 2027

• Weight

  From 2016 to 2027

• Height

  From 2016 to 2027

• BMI

  From 2016 to 2027

Study Arms (4)

Control, SCI-1, SCI-2, SCI-3

Control: No spinal cord injury

Radiation: MRI

SCI-1

SCI-1: spinal cord injury and ASIA Grade A and B

Radiation: MRI

SCI-2

SCI-2: spinal cord injury and ASIA Grade C

Radiation: MRI

SCI-3

SCI-3: spinal cord injury and ASIA Grade D

Radiation: MRI

Interventions

MRI RADIATION

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

Control, SCI-1, SCI-2, SCI-3; SCI-1; SCI-2; SCI-3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• Complete and available imaging data, clinical data, including MRI, sex, age

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated 2 Hospital of Nantong University: lead

Study Sites (1)

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, 0513, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)