Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
研究概览
简要总结
The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their overall quality of life.
Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity.
This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available. Using neurofeedback equipment to teach patients ways to modify their own brain waves to lower the perception of symptoms and improve quality of life is considered investigational.
Up to 99 participants over the age of 18 will take part in this study. All will be enrolled at MD Anderson.
详细描述
Baseline Tests:
If you agree to take part in this study, you will have the following baseline tests:
- You will complete 7 questionnaires about your symptoms, how you have been feeling, and your general quality of life. It should take about 20 minutes to complete.
- Basic information about you (such as your age and education level) will also be collected.
- You will have an EEG to measure the electrical activity of your brain. During the EEG, researchers will place a cap containing 19 electrodes on your scalp and 1 electrode on each earlobe. The electrodes will measure and record your brain wave activity, similar to the way a doctor listens to your heart beat from the surface of your skin. The EEG should take about 45 minutes to complete.
Study Groups:
After completing the baseline tests, you will be randomly assigned (as in the roll of a dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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-
- •Pain score >/= 4 on a 0-10 numeric pain scale and/or grade 3 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 report neuropathic pain 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.
- •Willing to come to MD Anderson for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA's Regional Care Centers.
- •Patients who are 18 years of age or above
- •Patients who have a diagnosis of breast cancer.
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
Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
时间窗: 4 months
Pain Quality Assessment Scale (PQAS) used to evaluate responses in each group.
次要结局
- Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN)(4 months)