Trial of Self-Applied Transcutaneous Auricular Vagus Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy
Single-Arm Bayesian Phase II Trial of Self-Applied Transcutaneous Auricular Vagus Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy
This purpose of this study is to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS) improves chemotherapy-induced peripheral neuropathy (CIPN) symptoms by assessing changes in daily symptom trajectories following treatment initiation. The study will also examine potential mechanisms of action through longitudinal assessment of inflammatory biomarkers, corticospinal excitability, and autonomic nervous system function.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Marlon L Wong, PT, PhD
- 邮箱：mwong2@miami.edu
研究联系人备份
- 姓名：Richard A Martinez, MS
- 电话号码：3052842359
- 邮箱：rxm1388@med.miami.edu
学习地点
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-
Florida
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Miami、Florida、美国、33136
- Christine E Lynn Rehabilitation Center
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接触：
- Marlon L Wong, PT, PhD
- 邮箱：mwong2@miami.edu
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接触：
- Richard A Martinez, MS
- 电话号码：3052842359
- 邮箱：rxm1388@miami.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-80 years
- Prior exposure to platinum, taxane, or vinca alkaloid chemotherapy
- Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy
- Worst CIPN-related symptom ≥4/10 over the last week
Exclusion Criteria:
- Unstable cardiac disease/Known arrhythmias
- Head or neck cancer or metastases
- Recent ear trauma or active dermatologic disease at the stimulation site
- <2 months since completion of cancer treatment or surgery (i.e, tumor resection, radiation therapy, and/or taxane/platinum/vinca alkaloid chemotherapy treatments. Maintenance therapies, including hormonal therapy or Poly (ADP-ribose) Polymerase (PARP) inhibitors, are allowed and not part of exclusion criteria. Patients may have pending reconstructive surgeries planned as long as it is planned outside of the study participation window.)
- Metal implants in the head or neck (e.g., cochlear implant)
- Implanted electronic or magnetic devices (e.g., pacemaker, medication pumps, other implanted neurostimulation systems)
- Known allergy to tape/adhesives
- History of seizure/epilepsy, intracranial pathology, or other neurological condition associated with increased seizure risk
- Pregnancy or actively breast feeding
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Auricular Vagus Nerve (AVNS) Group
Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes. |
Participants will self-administer transcutaneous auricular vagus nerve stimulation (taVNS) using the Sparrow Link portable stimulator and flexible ear electrodes for 1 hour daily for 14 days (total stimulation time: 14 hours).The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Daily Chemotherapy-Induced Peripheral Neuropathy Symptom Severity Measured by Numeric Rating Scale (NRS)
大体时间：Baseline (Days -14 to 0), Treatment period (Day 1-14)
|
Participants will complete a daily electronic diary rating the severity of their most bothersome chemotherapy-induced peripheral neuropathy (CIPN) symptom (pain, numbness/tingling, burning, pressing/squeezing, or electric shocks) during the previous 24 hours using an 11-point Numeric Rating Scale (NRS), where 0 = no symptoms and 10 = worst imaginable symptoms. The primary analysis evaluates symptom trajectories using daily observations collected during the baseline and treatment periods. |
Baseline (Days -14 to 0), Treatment period (Day 1-14)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20)
大体时间：Baseline (Day 0), Day 15, and Day 45 follow-up
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) is a validated 20-item questionnaire that assesses sensory, motor, and autonomic neuropathy symptoms. Responses are transformed to 0-100 subscale scores, with higher scores indicating greater symptom severity. |
Baseline (Day 0), Day 15, and Day 45 follow-up
|
合作者和调查者
调查人员
- 首席研究员：Marlon L Wong, PT, PhD、University of Miami
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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