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临床试验/NCT04759443
NCT04759443招募中不适用

Detection of Small Fiber Neuropathy Using Skin Properties

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Diagnostic accuracy of image processing

研究概览

简要总结

Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

详细描述

Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.

The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.

This approach can improve the availability of diagnosis of small fiber neuropathy.

研究设计

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

入排标准

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

入选标准

  • Patients with age 18 year or older
  • Patients that sign the informed consent form to participate in this study
  • Patients completed the autonomic testing with skin biopsies

排除标准

  • Patients with significant hairs at the legs that will cover the skin
  • Any dermatological disorder that can affect the skin composition
  • The use of skin lotion

结局指标

主要结局

Diagnostic accuracy of image processing

时间窗: 2 years

The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.

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

Peter Novak

Director, Autonomic Laboratory

Brigham and Women's Hospital

研究点 (1)

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