Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Decrease in Neuropathic Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are:
To examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity.
To examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN.
Researchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to use smart phone and willing to receive text messages/emails
- •Has CIPN disorder/neuropathic pain related to chemotherapy
- •Able and willing to follow instructions
- •Not participated in any other clinical study within the past two months that may influence the results of this study
排除标准
- •History of seizures
- •Hydrocephalic
- •Had a change in medical therapy related to the treatment of neuropathy or chronic pain in the last fourteen days
- •Received repetitive transcranial magnetic stimulation (rTMS) in the last 60 days
- •Implanted device or metal in the brain
- •History of brain bleed in the last six months
- •History of suicidal behavior, bipolar disorder, schizophrenia
- •Active radiation over the scalp
- •Brain metastases
- •Currently participates in other neuropathic pain studies
- •Has any other medical condition that would prevent them from participating, including scalp wounds, hyperhidrosis, sensitive scalp, rash
研究组 & 干预措施
Treatment Device
干预措施: SHIFT (Device)
Sham Device
干预措施: SHIFT (Device)
结局指标
主要结局
Decrease in Neuropathic Pain Intensity
时间窗: 12 weeks
Measured through scores in the Neuropathy Pain Scale. The Neuropathy Pain Scale uses a range a 0 to 10, with 0 being no pain/sensation and 10 being the most intense pain/sensation imaginable.
Decrease in Numeric Pain Rating.
时间窗: 12 weeks
Measured through Numeric Pain Rating surveys. The numeric pain rating scale uses a range of 0 to 10, with 0 being no pain and 10 being the worst pain possible.
Improvement in Neuropathic Pain Symptoms
时间窗: 12 weeks
Measured in weekly scores in the Neuropathic Pain Symptom Inventory. The inventory uses a scale of 1 to 10, with 1 being the no symptom and 10 being the worst symptom imaginable.
次要结局
- Decrease of pain-related stress(12 weeks)
- Decrease of pain-related anxiety(12 weeks)
- Decrease of pain-related interference(12 weeks)
- Decrease of pain-related inflammatory markers(12 weeks)