Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adherence to Myovolt focal vibration
研究概览
简要总结
This study will perform an early Phase I feasibility study with single-arm, double-baseline repeated measured design. The investigators will test the feasibility of using focal vibration to improve symptoms of persistent CIPN.
详细描述
This is an initial Phase I single-site, single-arm, double-baseline repeated measures feasibility study of wearable focal vibration (FV with Myovolt) for persistent chemotherapy-induced peripheral neuropathy. We will enroll up to 15 cancer survivors who are cancer-free and meet all other inclusion/ exclusion criteria, including CIPN symptoms at least 3 months after final chemotherapy infusion. Participants will undergo baseline assessments (V1) of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline (V2). In addition, they complete 7-days of baseline symptom monitoring by diary before starting 6 weeks of daily at-home therapy with a Myovolt wearable FV device. A study coach will check in by phone or video calls during the intervention period. Participants undergo post-testing immediately after the 6-week intervention (V3), and after another 6 weeks without FV (V4). In total, participants attend 3-4 onsite study visits, a 6-week intervention period with weekly remote check-in contact from the study team, and a 6-week intervention-free follow-up period with at least one remote check-in. Participants will keep a provided daily symptom diary during the primary study period (i.e., 6 weeks), and at least weekly in the 6-week follow-up period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Cancer patients with current symptoms of chemotherapy induced peripheral neuropathy affecting the feet, persisting for at least 3 months after completion of chemotherapy, and not substantially improving in recent weeks. The CIPN must be painful, or severe enough to interfere with function, activities, or participation (generally NCI-CTCAE Grade II)
- •Clinically stable to participate in study assessments and the intervention (at a minimum, able to stand independently from a chair and walk household distances without help from another person)
- •Able to read and speak English, give a voluntary written consent
- •Sufficient cognition to consent, confirmed by recall of key study points
- •Use of pain medications (opioids, anti-convulsants, and antidepressants) must be stable in the two weeks prior to study enrollment, and the participant must agree to avoid significant changes in pain medication regimen during the period of active study participation, and to notify the study team if medications change
排除标准
- •Neuropathy (known or suspected) of any etiology other than chemotherapy or diabetes (for example, due to alcohol, vitamin deficiency, autoimmune disorder, CMT, idiopathic
- •Unsafe/unable to self-apply the focal vibration intervention for any reason (for example, insufficient hand dexterity or cognitive executive function
- •Recent or fluctuating musculoskeletal injury or lesion that would impact physical performance
- •Lower limb deficiency/amputations
- •Pregnant, or planning to get pregnant in the next 6 months. Pre-menopausal females who enroll agree to notify the study team as soon as possible should they become pregnant
研究组 & 干预措施
Focal vibration therapy
Myovolt delivers vibration with a frequency between 50-80 Hz. Myovolt intensity will be set to ~up to 2X the participant's initial Myovolt perception threshold. If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.
干预措施: Focal vibration therapy (Device)
结局指标
主要结局
Adherence to Myovolt focal vibration
时间窗: After 6-week intervention
Number of completed days and sessions of Number of days (or sessions) the intervention was worn, as a percentage of the number of days (or sessions) the device was prescribed.
Feasibility of enrollment
时间窗: Baseline
Percent of interested individuals who enrolled.
Feasibility of Enrollment
时间窗: Baseline
Percent of interested individuals who enrolled.
Adherence to Myovolt Focal Vibration
时间窗: After 6-week intervention
Number of completed sessions the intervention was worn, as a percentage of the number of sessions prescribed.
次要结局
- Global Rating of Change (GROC) scale(After 6-week withdrawal period)
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory(Change from Baseline after 6-week Intervention)
- Long-term retention(After 6-week withdrawal period)
- Neuropathy Total Symptom Score-6 (NTSS-6)(Change from Baseline after 6-week Intervention)
- Toe Strength using a quantifiable toe measurement device(Change from Baseline after 6-week Intervention)
- Manual Muscle Testing (MMT) of Toes(Change from Baseline after 6-week Intervention)
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale(Change from Baseline after 6-week Intervention)
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale(Change from Baseline after 6-week Intervention)
- Vibration Perception Threshold using Biothesiometer(Change from Baseline after 6-week Intervention)
- Patient Neurotoxicity Questionnaire (PNQ)(Change from Baseline after 6-week Intervention)
- Global Rating of Change (GROC) Scale(After 6-week intervention)
- Change in Toe Strength Using a Proprietary Quantifiable Toe Measurement Device, Quantification of Hallux Extension Strength or QuHalEx(TM), U.S. Patent 11402284 Issued to the University of Oklahoma on 08/02/2022, and Provisional Patent 63/627,850.(Change from Baseline after 6-week Intervention)
- Vibration Perception Threshold Using Biothesiometer(Change from Baseline after 6-week Intervention)