NL-OMON53010招募中不适用
Improving the clinical usefulness of skin biopsy in small fiber neuropathy: examining the intraepidermal nerve fiber density dynamic longitudinally and the importance of adding the proximal/distal ratio - Improving the clinical usefulness of skin biopsy in small fiber neuropathy
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 280 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Group 1 (n=40) Idiopathic SFN, with normal IENFD:
- •a) Male and female subjects of 18 years or older.
- •b) >=2 positive answers on the SFN-SIQ, not otherwise explained.
- •c) Normal IENFD and abnormal TTT, according to the international normative
- •values,3,23 during the regular visit in our clinical center at least one year
- •d) Written informed consent.Group 2 (n = 40) Sodium channelopathy-related SFN,
- •with normal IENFD:
- •a) Male and female subjects of 18 years or older.
- •b) >=2 positive answers on the SFN-SIQ, not otherwise explained.
- •c) Normal IENFD and abnormal TTT, according to the international normative
- •values,3,23 during the regular visit in our clinical center at least one year
- •d) Possibly pathogenic, probably pathogenic or pathogenic NaV1.7, Nav1.8 and/or
- •NaV1.9 variant
- •a) Written informed consent.Group 3 (n=140) Healthy subjects (only
- •proximal/distal IENFD ratio study)
- •a) Male and female subjects of 18 years or older.
- •b) Written informed consent.Group 4 (n = 20) Idiopathic SFN, with abnormal
- •IENFD (only proximal/distal IENFD ratio study)
- •a) Male and female subjects of 18 years or older.
- •b) >=2 positive answers on the SFN-SIQ, not otherwise explained.
- •c) Abnormal IENFD, according to the international normative values, during the
- •regular visit in our clinical center at least one year ago.
- •d) Written informed consent.When it appears that the proximal/distal ratio is
- •abnormal in patients with an abnormal TTT, but normal IENFD, the study will be
- •extended with an extra group of patients:Group 5 (n=40) Idiopathic clinical
- •SFN, with both normal IENFD and TTT
- •a) Male and female subjects of 18 years or older.
- •b) >=5 positive answers on the SFN-SIQ, not otherwise explained.
- •c) Patients with a normal IENFD and normal TTT, according to the international
- •normative values, during the regular visit in our clinical center at least one
排除标准
- •All patient groups:
- •a) Underlying cause of SFN (diabetes, hypothyroidism, renal failure, vitamin
- •B12 deficiency, monoclonal gammopathy, alcohol abuse (more than 5 IU/day),
- •malignancies, drugs that cause neuropathy (e.g. chemotherapy, amiodarone,
- •propafenone)).
- •b) Large nerve fiber involvement (i.e. weakness, loss of vibration sense,
- •hypo-/areflexia, abnormal nerve conduction studies).Groups 1, 4 and 5
- •a) Possibly pathogenic, probably pathogenic or pathogenic NaV1.7, Nav1.8 and/or
- •NaV1.9 variant.Healthy subjects
- •a) >1 positive answer on the SFN-SIQ.
- •b) A history of peripheral neuropathy.
- •c) Signs of peripheral neuropathy in neurological examination.nt claCC
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