NCT02432677Unknown2 期
Evaluation of the Potentiating Effect of Transcranial Direct Current Stimulation (tDCS) on Opioid Analgesia of Pain Threshold in Humans
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Thresholds of pain to the cold pressor test (CPT)
研究概览
简要总结
The purpose of this study is to evaluate the potential additive effect of tDCS compared to placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in healthy volunteers .
详细描述
Pain is a prevalent symptom in medicine and the role of various opioids is valuable in the treatment of moderate to severe pain. Several technologies of brain stimulation , including transcranial direct current stimulation ( tDCS) are emerging as therapeutic options for many pain conditions. The effect of tDCS was demonstrated in sensory perception , decreasing the threshold for acute pain in healthy volunteers and in various chronic pain conditions . There is evidence about the use of tDCS with the participation through many mechanisms in cortical modulation , including the regulation of neurotransmitters, including opioids. In the context of neurostimulation, opioidergic system and cortical pain modulation, emerge the hypothesis of a possible potentiating effect of tDCS on clinical application of opioid analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Without medication
- •Sign the informed consent
排除标准
- •Patients who did not understand the Portuguese
- •Acute or chronic pain conditions
- •Medical or psychiatric disorders
- •History of sleep disorders (apnea, hypersomnia, somnambulism...)
- •History of alcohol or substance abuse
- •Neurological disorder
- •Use of anti-inflammatory drugs, steroids and non-steroids, opioid and non-opioid analgesics, psychiatric medications, anticonvulsants, alpha and beta blockers
- •Traumatic brain injury
- •Neurosurgery
- •Metallic implant in the brain
研究组 & 干预措施
Remifentanil + Active tDCS
Experimental
- tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes.
- Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Remifentanil (Drug)
Remifentanil + Active tDCS
Experimental
- tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes.
- Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Active tDCS (Device)
Placebo + Active tDCS
Other
- tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes.
- Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Active tDCS (Device)
Placebo + Active tDCS
Other
- tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes.
- Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Placebo (Drug)
Remifentanil + Sham tDCS
Other
- Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
- Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Remifentanil (Drug)
Remifentanil + Sham tDCS
Other
- Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
- Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Sham tDCS (Device)
Placebo + Sham tDCS
Other
- Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
- Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Sham tDCS (Device)
Placebo + Sham tDCS
Other
- Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
- Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
干预措施: Placebo (Drug)
结局指标
主要结局
Thresholds of pain to the cold pressor test (CPT)
时间窗: 20min
次要结局
- Sedation level in the visual analogue scale (VAS)(60min)
- Serum levels of BDNF(20min)
- Threshold of pain to the thermal stimulus (TT)(20min)
- Intensity of electrical brain activity in the bi-spectral index (BIS)(60min)
- Conditioned pain modulation (CPM)(20min)
- Temperature of tolerance to the thermal stimulus (TTTS)(20min)
- Hemodynamic changes of brain using fNIRSNear-infrared spectroscopy (NIRS)(60)
研究者
研究点 (1)
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