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临床试验/NCT07341997
NCT07341997招募中不适用

Environmental Factors Associated With Peripheral Neuropathies in French Guiana

Admin CIC2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年12月8日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
2
主要终点
Comparison of exposure rates among cases and controls

研究概览

简要总结

Peripheral neuropathies (PN) affect 1% of the global population, particularly the elderly. About 20-30% of cases remain unexplained. In French Guiana, we hypothesize that factors like neurotoxic traditional plant remedies, arboviral disease outbreaks, and mercury exposure from illegal gold mining may contribute to PN. The study aims to assess the association between PN and exposure to arboviral infections, heavy metals, and plant consumption in French Guiana.

详细描述

Peripheral neuropathies (PN) affect 1% of the global population, with higher prevalence in the elderly. They lead to gait disorders and chronic pain, severely impacting quality of life. Despite thorough investigations, 20-30% of cases have no identified cause. In French Guiana, unique factors may contribute to these neuropathies, including the use of potentially neurotoxic traditional plant remedies and outbreaks of arboviral diseases, which can complicate conditions like Guillain-Barré syndrome. Additionally, illegal gold mining exposes residents to mercury, both directly and through environmental contamination. We hypothesize that these local factors might explain the unidentified cases of PN and exacerbate neuropathies in patients with pre-existing nerve vulnerability, such as diabetic neuropathy.

This is a prospective multicenter case-control study being conducted in hospitals in Cayenne and Saint-Laurent du Maroni. At the inclusion visit, blood samples will be taken to assess arbovirus serology, particularly for Zika, Chikungunya and Dengue, as well as to measure levels of heavy metals, including mercury and lead. In addition, urine and hair samples will be taken to analyze these heavy metals. Participants will also fill in a questionnaire about their plant consumption.

They will not be followed as part of the research.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • For the Case group: patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy
  • For the Control group: patients hospitalized or consulting at the hospitals in Cayenne and Saint-Laurent du Maroni, without peripheral neuropathy.

排除标准

  • For the Case and Control groups: patients under the age of 18, those who object to participation and those who are unable to complete the questionnaire.

研究组 & 干预措施

Control group

Active Comparator

Patients hospitalised or consulting at hospitals in Cayenne and Saint-Laurent du Maroni who do not have peripheral neuropathy.

干预措施: Case Group (Other)

结局指标

主要结局

Comparison of exposure rates among cases and controls

时间窗: At inclusion

The primary endpoint will be the comparison of rates of exposure to arboviruses, heavy metals and consumption of potentially neurotoxic plants in cases and controls. The heavy metals assay and the questionnaire will be carried out at the inclusion visit.

次要结局

  • Genetic mutations indentification(At inclusion)
  • Peripheral Nerve Disability (PND) determination(At inclusion)

研究者

发起方
Admin CIC
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Admin CIC

Nathalie DESCHAMPS

Centre Hospitalier de Cayenne

研究点 (2)

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