Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain
研究概览
简要总结
The goal of this study is to learn if using a non-invasive therapy called "neurofeedback training" can help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.
详细描述
Baseline:
On Day 1, the following baseline tests and procedures will be performed:
- You will fill out 10 questionnaires about your pain, fatigue, how you have been feeling, and your general quality of life. The questionnaire packet may take up to 1 hour to complete.
- You will have an electroencephalograph (EEG -- a test that measures the electrical activity of the brain) performed. The EEG should take about 1 hour to complete.
Study Groups:
If you choose to take part in this study, after completing the baseline tests and procedures, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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-
- •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.
- •Pain must be related to chemotherapy (in the opinion of the treating physician).
- •Patients must have had 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 3 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 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.
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.
研究组 & 干预措施
EEG biofeedback (BF) Group
Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
干预措施: EEG biofeedback (BF) Group (Behavioral)
EEG biofeedback (BF) Group
Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
干预措施: Follow UP Questionnaires (Behavioral)
Wait-List Control (WLC) Group
Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
干预措施: Wait-List Control (WLC) Group (Behavioral)
Wait-List Control (WLC) Group
Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
干预措施: Follow UP Questionnaires (Behavioral)
结局指标
主要结局
Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain
时间窗: 10 weeks
After Group 1 has completed neurofeedback training, both Groups will fill out the same 10 questionnaires that were completed at baseline. An EEG will be performed on both Groups about 1 week after Group 1 completes last neurofeedback training, and again 4 months later.
次要结局
未报告次要终点