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临床试验/CTRI/2024/04/065814
CTRI/2024/04/065814招募中不适用

Assessment of serum neurofilament light chains in leprosy associated peripheral neuropathy

Indian Association of Dermatology, Venereology and Leprosy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
To assess the serum levels of neurofilament light chains in patients with peripheral neuropathy of leprosy and compare it with levels in patients of leprosy without peripheral neuropathy, and healthy controls

研究概览

简要总结

Leprosy causes a peripheral sensory-motor neuropathy with affliction of sensory pathways usually preceding motor involvement. The nerve damage is a major cause of disability related to leprosy and contributes significantly to the stigma associated to the infection as well. Although effective multi drug therapy works to clear the bacterial load, the occurrence of peripheral neuropathy does not seem to be prevented and its occurrence, progression and recovery is unpredictable. Steroids are not uniformly effective in treating the peripheral neuropathy and newer drugs are urgently required to manage this distressing complication of leprosy.

Serum neurofilament light chains (NFL) were initially assessed in CSF in neurodegenerative disorders like Alzeihmer’s disease and multiple sclerosis. The significance in many such disorders is now well established and the marker is now used for treatment assessment in therapeutic trials of these diseases as well. With the advent of highly sensitive single molecular arrays (SIMOA), it is now possible to measure very small levels of NFLs in serum too. Further, in past few years the marker has been evaluated in some peripheral neuropathies also and shown to be of relevance. With this background we aim to assess serum NFL levels in patients with peripheral neuropathy of leprosy and compare it with levels in patients of leprosy without peripheral neuropathy, and healthy controls, to understand whether NFL can have a role in early detection of peripheral neuropathy of leprosy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult Patients diagnosed with leprosy with and without peripheral neuropathy.
  • Age and sex matched healthy controls.

排除标准

  • Any alternate diagnosis of peripheral neuropathy
  • Presence of diabetes
  • History of chronic alcoholism.

结局指标

主要结局

To assess the serum levels of neurofilament light chains in patients with peripheral neuropathy of leprosy and compare it with levels in patients of leprosy without peripheral neuropathy, and healthy controls

时间窗: 6 months

次要结局

  • To understand the role of neurofilament light chains in the early detection of peripheral neuropathy in leprosy patients(6 months)

研究者

发起方
Indian Association of Dermatology, Venereology and Leprosy
申办方类型
Other [Official Society of Indian Dermatologists]
责任方
Principal Investigator
主要研究者

Ananta Khurana

Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital

研究点 (1)

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