A Feasibility Study of Smartphone-based Brainwave Entrainment (BWE) Technology as a Novel Treatment for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Qualitative data from semi-structured interviews
研究概览
简要总结
Is brainwave entrainment a feasible tool for managing long-term pain in a patient population in the home-setting? Long-term pain affects 4 in 10 people in the UK and can impact on all aspects of life. Many people find that their pain is not well controlled on the treatments that are currently available, or they experience unpleasant side-effects from painkillers. There is therefore an urgent need for new safe and effective treatments for long-term pain.
One new approach to treatment is to target alpha brainwaves - rhythmic brain activity that is known to be associated with reduced pain. Alpha brainwaves can be increased by looking at flashing lights or listening to rhythmic sounds at the same rhythm as the brainwaves. This is known as "brainwave entrainment" (BWE) and can be delivered through a smartphone application.
The aim of this study is to test the suitability, acceptability and benefits of the brainwave entrainment smartphone application for people with long-term pain, and to inform the design of a future larger study.
The investigators aim to recruit 40 participants. Individuals may be eligible if they are over 18 years old and have suffered persistent pain for longer than 3 months. Participants will attend a 3-hour session in the laboratory in either Manchester or Leeds. They will undergo brainwave entrainment for different lengths of time whilst their brain activity and pain levels are recorded to determine the most effective "dose" of entrainment for that individual. They will then use the smartphone application at home 3 times a day for 4 weeks, and will complete pain, sleep, fatigue and quality of life questionnaires. At the end of the study, the investigators will conduct interviews to gain in-depth feedback. The total duration for each participant is around 7 weeks. This study is funded by a Leeds Cares Clinical Research Fellowship.
详细描述
Primary Question/Objective:
The principal research objectives are two-fold:
- Firstly, to understand the dose-response of alpha BWE.
- Secondly, to test the feasibility of using alpha BWE technology for managing chronic pain in the home environment and to inform the design of a future clinical trial.
Secondary Question/Objective:
- To identify any issues with recruitment or retention of participants.
- To test the acceptability and usability of the intervention.
- To test the acceptability of the outcome measures and methods of data collection.
- To gain an understanding of the effect size in order to calculate how many participants will be required for a future clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Neither the researcher delivering the intervention nor the participant will know the selected sequence at the start, however, it will not be possible for either the researcher or the participant to be completely blinded to the sequence once it is underway, given that the differences in duration of stimulation are likely to be quite apparent.
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
- •adults over the age of 18 years (there is no upper age limit as we would want the intervention to be as inclusive as possible)
- •clinically significant non-cancer-related chronic pain (for which they have sought medical input) for more than three months' duration
- •willing and able to consent to taking part.
排除标准
- •any history or first-degree relative history of epilepsy or convulsions/seizures
- •discomfort with flashing lights
- •history of recurrent headaches or migraines
- •participants who have difficulty understanding verbal or written English, or who have cognitive or mental health problems that would prevent them being able to provide written informed consent
- •planned intervention (surgery, new medications or treatments) during the study period.
结局指标
主要结局
Qualitative data from semi-structured interviews
时间窗: 2 years
This will answer key feasibility questions to enable planning of a future clinical trial. This will include information on acceptability and usability of the intervention, feedback on the outcome measures used, engagement with the research, process issues including recruitment, and the extent to which they felt the intervention improved their pain.
Numerical pain ratings (NRS)
时间窗: 2 years
0-10 where 0 = no pain and 10 = worst pain. To indicate whether there is a dose-related change in efficacy of BWE.
次要结局
- Electroencephalography data(1 year)
- Brief Pain Inventory (BPI)(2 years)
- Pittsburgh sleep quality index (PSQI)(2 years)
- EuroQol - 5 dimensions (EQ-5D)(2 years)
- Multidimensional Fatigue Inventory (MFI)(2 years)
研究者
Helen Locke
Clinical Research Fellow
University of Manchester