Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Retention Rate (taVNS Intervention Cohort)
研究概览
简要总结
The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy-induced peripheral neuropathy (CIPN) group:
- •Age 18-80 years
- •Prior exposure to platinum or taxane chemotherapy
- •Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy
- •Worst CIPN-related pain ≥4/10 over the last week
- •Registry Cohort:
- •Age 18-80 years
- •Prior exposure to platinum or taxane chemotherapy
- •Denis any current neuropathic symptoms as described above.
排除标准
- •All participants:
- •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
- •Metal implants in the head or neck (e.g., cochlear implant)
- •Implanted electronic devices (e.g., pacemaker)
- •Known allergy to tape/adhesives
- •History of seizure/epilepsy, intracranial pathology, or skull defect
- •Pregnancy
结局指标
主要结局
Retention Rate (taVNS Intervention Cohort)
时间窗: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Retention Rate (Prospective Registry Cohort)
时间窗: Baseline (Day 0 (T0) and Day 14 (T2)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Recruitment Rate (taVNS Intervention Cohort)
时间窗: Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)
Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study.
Acceptability (taVNS Intervention Cohort)
时间窗: Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)
Acceptability will be measured as the percentage of participants reporting overall acceptable or satisfactory experiences with the intervention during exit interviews. Acceptability will be considered successful if ≥ 80% of participants provide favorable responses.
Treatment Adherence (taVNS Intervention Cohort)
时间窗: 14 days of intervention
Treatment adherence will be assessed using the unique device-generated code associated with each taVNS session. Adherence will be considered successful if participants complete ≥ 80% of planned sessions as documented by device-logged session codes. Adherence will be calculated as: Number of completed session codes ÷ Number of programmed session codes) × 100 over the 14-day treatment period.
次要结局
- Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort)(Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3))
- Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort)(Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3))
- Change in Serum Neurofilament Light Chain (NfL)(Baseline (Day 0 (T0), to Day 14 (T2))
- Change in Serum Interleukin-1 Beta (IL-1β)(Baseline (Day 0 (T0) to Day 14 (T2))
- Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)(Baseline (Day 0 (T0) to Day 14 (T2))
- Change in Serum Interleukin-6 (IL-6)(Baseline (Day 0, (T0) to Day 14 (T2))
- Change in SICI (neurophysiological measure of corticospinal excitability)(Baseline (Day 0 (T0) to Day 14 (T2))
- Change in Heart rate variability (HRV, surrogate measure of autonomic balance)(Baseline (Day 0 (T0) to Day 14 (T2))
研究者
Marlon Wong
Associate Professor of Clinical
University of Miami