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Clinical Trials/NCT06697392
NCT06697392
Active, not recruiting
Not Applicable

Ultrasound-based Artificial Intelligence for Grading of Carpal Tunnel Syndrome, a Multicenter Study in China

Peking University People's Hospital1 site in 1 country500 target enrollmentNovember 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome (CTS)
Sponsor
Peking University People's Hospital
Enrollment
500
Locations
1
Primary Endpoint
grading of CTS
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Carpal tunnel syndrome (CTS) is one of the most prevalent peripheral neuropathies, impacting approximately 4% of the general population. It is typically classified into three degrees: mild, moderate, and severe. Accurate grading of carpal tunnel syndrome (CTS) is essential for determining appropriate treatment options, thereby playing a crucial role in optimizing patient outcomes. Electrophysiological testing (EST) is a key parameter for grading carpal tunnel syndrome (CTS). However, it is limited by several factors, including its invasive nature, poor reproducibility, and reduced sensitivity for detecting early-stage disease. Recently, ultrasound has gained widespread acceptance among clinicians for the assessment and grading of CTS. Nonetheless, radiologists often encounter challenges in this process due to the variability in image quality, differences in experience, and inherent subjectivity.

To address these issues, artificial intelligence presents a promising solution. Therefore, this study aims to develop a deep learning model for grading CTS by leveraging multimodal imaging features, including B-mode ultrasound, superb microvascular imaging (SMI), and elastography. Additionally, the investigators intend to validate the model's effectiveness by testing it with images from various clinical centers, ensuring its generalizability across different clinical settings.

Registry
clinicaltrials.gov
Start Date
November 15, 2024
End Date
December 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shi Xiaochen

Doctor

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

  • those who have complained about associated symptoms about CTS, including pain, numbness, and weakness of hand.
  • those who perform ultrasound examinations of median nerve within 1 week of the symptom.
  • those who have electrophysilogical test results as reference standard.

Exclusion Criteria

  • those who had a surgery in the affected hand.
  • those who had a trauma or fracture in the affected hand.
  • those who had rheumatoid-related conditions, autoimmune diseases, and endocrine disorders.

Outcomes

Primary Outcomes

grading of CTS

Time Frame: baseline

Study Sites (1)

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