Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of a Home-Based Neurofeedback (HBNF) System
研究概览
简要总结
This trial studies how well a home-based neurofeedback program works in treating participants with chemotherapy-induced peripheral neuropathy (nerve damage that affects motor function). Neurofeedback training is a type of therapy that uses an electroencephalograph and a computer software program to measure brain wave activity. It may help teach participants how to change their own brain waves to lower their perception of pain symptoms and improve overall quality of life.
详细描述
PRIMARY OBJECTIVES:
I. Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
I. Estimate the effects of home-based neurofeedback (HBNF) on symptoms of (CIPN) versus a wait list (WL) control group in cancer patients.
II. Estimate the effects of home-based neurofeedback (HBNF), versus WL, on the cortical and subcortical brain regions associated with CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Neuropathic pain score >= 4 on a 0-10 numeric pain scale (numeric rating scale [NRS]) and/or grade 3 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.
- •Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
- •Patients must have had neuropathic symptoms for a minimum of 3 months.
- •No plans to change pain medication regimen during the course of the study.
- •Off active chemotherapy treatment for minimum of 6 months.
- •Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
- •Willing to come to MD Anderson for the intake and follow up data acquisition and to receive their equipment.
- •Willing to allow research staff to come to their homes or to return the equipment to MD Anderson (MDA) in the case of equipment malfunction.
- •Have had a diagnosis of cancer treated with chemotherapy.
- •Live within a 50 mile radius of MD Anderson's main campus.
排除标准
- •Patients who are taking any antipsychotic medications.
- •Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- •Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
- •Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
- •Patients who have a history of head injury or who have known seizure activity.
结局指标
主要结局
Feasibility of a Home-Based Neurofeedback (HBNF) System
时间窗: 6 weeks
HBNF intervention feasible if the average number of HBNF sessions completed across patients in the HBNF arm is \>= 15.0 (or on average the proportion of sessions completed is \>= 75%).
次要结局
- Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Effects of Home-Based Neurofeedback (HBNF) versus Waitlist (WL) Control Group determined by EEG,(Baseline and at 6 weeks)
- Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with CIPN Determined by Changes in EEG as Measured by Low Resolution Electromagnetic Tomography (LORETA).(Baseline and at 6 weeks)
- Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys(Baseline and within 7 days of the conclusion of treatment.)
- Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients(Baseline and at 6 weeks)