Effects of Non Invasive Brain Stimulation on Experimental Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Frequency of alpha peaks
研究概览
简要总结
Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial direct current stimulation (tDCS) has been widely investigated in research and clinical settings in order to modulate brain plasticity and improve clinical pain. Interestingly, newly developed paradigms i.e. tDCS of the resting state motor network have proved higher modulatory effects in terms of corticospinal excitability when compared to traditional M1 tDCS.
However, little is known about the effects of tDCS on the frequency changes of alpha oscillations (alpha peaks).
Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks during 1-hour experimental pain in comparison to baseline.
The present study aims to investigate the effects of tDCS of the resting state motor network on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.
详细描述
There is evidence that chronic pain alters the frequency of alpha peaks. Specifically, recent studies showed a correlation between decreased frequency of alpha peaks and perceived pain. Furthermore, a correlation was found between high pain sensitivity and slower alpha oscillations during prolonged pain during 1 hour.
To date, the effects of prolonged experimental pain during 24 hours on brain oscillations has not been explored. Moreover, it is unknown whether non invasive brain stimulation (NIBS) through transcranial direct current stimulation (tDCS) can revert these pain-related feature.
It is hypothesized that prolonged pain during 24 hours will reduce the frequency of alpha peaks and tDCS of the resting state motor network will revert it to baseline values.
Furthermore, it is thought that decreased frequency of alpha peaks will be correlated with perceived pain intensity on Day 1 (before receiving the first tDCS session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blinding is performed by a third-party which is not part of the research group
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed healthy men and women in the age 21-50 years who speak and understand English
排除标准
- •Lack of ability to cooperate
- •History of chronic pain or current acute pain
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Present and previous neurologic, musculoskeletal or mental illnesses
- •Chili allergies
- •Current use of medications that may affect the trial
- •Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
- •Failure to pass the questionnaire for tDCS
结局指标
主要结局
Frequency of alpha peaks
时间窗: 24 hours
The frequency of alpha peaks will be extracted through electroencephalography (EEG) in the sensorimotor areas (Central-Parietal) of the brain. It is hypothesized that the frequency of alpha peaks will be reduced due to prolonged pain. It is expected that tDCS of the resting state motor network will revert the frequency to baseline values or even higher.
Perceived pain intensity
时间窗: 24 hours
Perceived pain intensity will be rated in a 0-10 Numerical rating scale (NRS): 0 no pain and 10 worst pain imaginable. Prolonged pain will increase perceived pain intensity. It is expected that active tDCS will not be able to reduce perceived pain intensity in comparison to sham tDCS.
次要结局
- Power of alpha oscillations(24 hours)
- Amplitude of alpha peak(24 hours)
研究者
Luisina Gregoret
Biomedical engineer
Aalborg University