跳至主要内容
临床试验/NCT06697392
NCT06697392进行中(未招募)不适用

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

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
1
主要终点
grading of CTS

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

grading of CTS

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shi Xiaochen

Doctor

Peking University People's Hospital

研究点 (1)

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