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OpenTrials
Active, Not Recruiting

NCT Number: NCT06697392

Ultrasound-based Artificial Intelligence for Classification of Carpal Tunnel Syndrome

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ultrasound examination

Other

The investigators intend to perform ultrasound examinations for the participants with CTS.

Primary outcomes

  1. grading of CTS

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Nov 20, 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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