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NCT Number: NCT06436716

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, 0513, China

Location status: Recruiting

Location contact

Chunshuai Wu, Dr

CONTACT

[email protected]

Hongqing Xu, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MRI

Radiation

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

Primary outcomes

  1. MRI image

    Time frame: From 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.

  2. ASIA scores

    Time frame: From 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 outcomes

  1. Age

    Time frame: From 2016 to 2027

    Years old, no need month nor day

  2. Gender

    Time frame: From 2016 to 2027

    male and female

  3. Weight

    Time frame: From 2016 to 2027

    In kilograms

  4. Height

    Time frame: From 2016 to 2027

    In meters

  5. BMI

    Time frame: From 2016 to 2027

    In kg/m^2

Sponsors and collaborators

Lead sponsor

Affiliated 2 Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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