Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
研究概览
简要总结
This prospective observational pilot study will evaluate structural, functional, and patient-reported outcomes in adults with small fiber neuropathy who receive Saluda Evoke ECAP-controlled spinal cord stimulation as part of routine clinical care. The study does not assign, direct, or modify spinal cord stimulation therapy. All decisions regarding patient selection, trial stimulation, permanent implantation, and device programming are made independently by the treating physician according to standard clinical practice.
The primary objective is to assess change in intra-epidermal nerve fiber density from baseline to 12 months. Secondary objectives include evaluation of quantitative sensory testing, pain intensity, patient-reported outcomes, and correlations between changes in nerve fiber density, sensory function, and neuropathic pain outcomes.
The study will enroll up to 10 adult participants with clinically diagnosed small fiber neuropathy and chronic neuropathic pain. Research assessments include patient-reported outcome measures, quantitative sensory testing, review of available clinical records, and a 12-month follow-up skin biopsy for intra-epidermal nerve fiber density.
This aligns with the approved protocol: observational, 10 adults, 12-month participant follow-up, primary IENFD endpoint, and secondary QST/pain/correlation endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older.
- •Clinically diagnosed small fiber neuropathy based on abnormal intra-epidermal nerve fiber density (IENFD) skin biopsy.
- •Chronic neuropathic pain with Numeric Pain Rating Scale score of at least
- •Candidate for ECAP-controlled spinal cord stimulation therapy based on the - - - Principal Investigator's medical judgment.
- •Able and willing to undergo baseline and 12-month skin biopsies.
- •Able to comply with 12-month quantitative sensory testing.
- •Able to provide informed consent.
排除标准
- •Confounding factors that may independently contribute to small fiber damage or alter nerve fiber density, including uncontrolled diabetes defined as HbA1c greater than 8.5% within the last 3 months, autoimmune disorders such as lupus, or history of alcohol abuse.
- •Contraindications to spinal cord stimulation therapy, including active infection, coagulation disorders, allergy to medical device components, or other relevant surgical/device contraindications.
- •Uncontrolled medical or psychiatric conditions.
- •Pregnancy or planning to become pregnant during the study period.
结局指标
主要结局
Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
时间窗: Baseline to 12 months
Change in intra-epidermal nerve fiber density measured by skin biopsy from baseline to 12 months in participants with small fiber neuropathy receiving ECAP-controlled spinal cord stimulation as part of routine clinical care.
次要结局
- Change in Thermal Detection Thresholds From Baseline to 12 Months(Baseline to 12 months)
- Change in Numeric Pain Rating Scale Score Over 12 Months(Baseline, 1 week, 3 months, 6 months, and 12 months)
- Patient Global Impression of Change Score Over 12 Months(1-week, 3 months, 6 months, and 12 months)
- Correlation Between Change in IENFD and Change in Quantitative Sensory Testing Thresholds(Baseline to 12 months)
- Correlation Between Change in IENFD and Change in Pain Intensity(Baseline to 12 months)