Non-invasive Investigation of Excitability Changes in the Human Spinal Cord: the Effect of Transcutaneous Spinal Direct Current Stimulation (tsDCS) on Nociceptive Flexion Reflexes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in pain intensity rating
研究概览
简要总结
The aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for lower limb NFRs, but not for upper limb NFRs. Second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsDCS do affect the NFR in a polarity-dependent manner. Third, to investigate whether tsDCS effects observed on a spinal measure (NFR) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between the ages of 18 and 40 years
- •Having participated in the MRI medical assessment session and consented to taking part in 3T MRI measurements in written form
- •Having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form
- •Voluntary participation and signing of the study-specific consent form
排除标准
- •Existence of any contraindications for MRI measurements and magnetic/electric neurostimulation experiments
- •Pregnancy or breastfeeding
- •Very dry or sensitive skin (e.g., intolerance to creams/shampoos)
- •Chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- •Scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- •Acute sunburn in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- •Current or recurring pain
- •Injuries to the nervous system
- •History of or current neurological or psychiatric disorders
- •Chronic diseases that require permanent medication (e.g., asthma, diabetes mellitus, etc.)
- •Persons not capable of giving consent (e.g., in case of dementia)
- •Lack of consent with regards to report of incidental findings
结局指标
主要结局
Change in pain intensity rating
时间窗: Baseline and immediately after the intervention
One rating per trial on a standard visual analogue scale (VAS); internally numbered from 0 (no sensation) to 100 (unbearable pain)
Change in skin conductance response
时间窗: Baseline and immediately after the intervention
Amplitude maximum before onset of pain rating
Change in NFR amplitude
时间窗: Baseline and immediately after the intervention
90-150ms for lower limb, 60-200ms for upper limb
Change in heart period acceleration
时间窗: Baseline and immediately after the intervention
Amplitude maximum before onset of pain rating
次要结局
- Change in NFR area(Baseline and immediately after the intervention)