Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- EEG
研究概览
简要总结
This pilot trial studies how well neurofeedback training works in decreasing acute radiotherapy-induced pain in patients with head and neck cancer. Neurofeedback training is a type of therapy that uses electroencephalograph and a computer software program to measure brain wave activity. Neurofeedback training may 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
PRIMARY OBJECTIVES:
I. Determine the effects of an individualized LORETA (low resolution electromagnetic tomography) Z score neurofeedback program on changes in brain function using EEG (electroencephalography), qEEG (quantitative electroencephalography), and LORETA from immediately before to after each session in patients with head and neck cancer undergoing radiotherapy and experiencing pain.
SECONDARY OBJECTIVES:
I. Examine the effects of an individualized LORETA Z score neurofeedback program on perceptions of radiation-induced pain in head and neck cancer patients from immediately before neurofeedback training to immediately after neurofeedback training.
II. Identify brain regions from qEEG and LORETA that are associated with a non-pain state and then an acute pain state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must not have pain > 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy
- •Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer
- •No plans to change the type of pain medication during the course of the study
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 head or neck pain from other pain syndromes or chronic pain requiring analgesics
- •Patients with a history of seizure disorders
研究组 & 干预措施
Supportive care (neurofeedback)
Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training QID TIW for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.
干预措施: LORETA Neurofeedback Training (Other)
Supportive care (neurofeedback)
Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training QID TIW for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
EEG
时间窗: Baseline up to 1 week
The qEEG normative database is grouped by age and contains a sufficiently large sample size with means and standard deviations of the EEG time series and/or frequency domain analysis computed for each age group.
Neurofeeback (LORETA)
时间窗: Up to 5 years
The LORETA software package is used to perform the statistical analyses. The methodology used is non-parametric. It is based on estimating, via randomization, the empirical probability distribution for the max-statistic (e.g. the maximum of a t or an F statistic), under the null hypothesis. This methodology corrects for multiple testing (i.e., for the collection of tests performed for all electrodes and/or voxels, and for all time samples and/or discrete frequencies. Due to the non-parametric nature of the method, its validity need not rely on any assumption of Gaussianity.
次要结局
- The Social Provisions Scale (SPS)(Up to 5 years)
- The Multidimensional Pain Inventory (MPI)(Up to 5 years)
- The Brief Pain Inventory (Short Form)(Up to 5 years)
- M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN):(Up to 5 years)
- Pain medication use(Up to 5 years)
- Visual analog scale to assess pain(Up to 5 years)