Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in pressure pain tolerance.
研究概览
简要总结
The purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (HD-tDCS) on an experimental prolonged pain model in healthy subjects.
详细描述
The purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (HD-tDCS) on an experimental prolonged pain model in healthy subjects. Forty healthy participants are administered the compound Nerve Growth Factor (NGF) in the right first dorsal interosseous muscle (FDI), which produced prolonged muscle soreness and hyperalgesia.
The forty participants are randomly allocated to either the control group receiving a Sham-tDCS paradigm, or the intervention group receiving three consecutive days of multimodal HD-tDCS targeting primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) simultaneously.
The somatosensory profile is assessed at baseline, before administration of NGF as well as prior and post each HD-tDCS session using standardised quantitative sensory testing.
It is hypothesised that the active HD-tDCS will modulate the neurological changes induced by the experimental pain condition, which will alleviate the hyperalgesia and hypersensitivity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants are pseudo-randomly allocated to either the intervention or the control group so as the two groups are equally weighted on gender.
Using the build in double-blind software of the HD-tDCS device, the participant as well as investigator is blinded to the protocol that is administered.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women.
- •Able to speak, read and understand English or Danish.
排除标准
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Current use of opioids, antipsychotics, benzodiazepines
- •Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
- •Current or prior chronic pain conditions
- •Lack of ability to cooperate
结局指标
主要结局
Change in pressure pain tolerance.
时间窗: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold at baseline. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle. The participant is asked to rate the pain on a numerical rating scale (NRS) from 0-10. 0 representing no pain at all, and 10 representing the worst pain imaginable.
Change in pressure pain threshold.
时间窗: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle.
次要结局
- Change in conditioned pain modulation (CPM)(Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.)
- Change in electroencephalography response (EEG).(Three assessments over three days: The EEG will be recorded as a part of the HD-tDCS intervention.)
- Change in mechanical pain threshold(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
- Change in temporal summation of pain (TSP).(Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.)
- Change in tactile detection threshold(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
研究者
Sebastian Kold Sørensen
Ph.D. fellow
Aalborg University