The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
The study is a randomized clinical trial that is assessing the effects of sensory training on pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (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
- •Able to provide informed consent to participate in the study
- •Able to perform physical activities such as cycling
- •18-40 years old
- •Practice of moderate intensity aerobic physical activity less than 150 minutes per week
排除标准
- •Hypertension
- •Cardiovascular disease
- •Subjects with pacemakers, and/or implantable cardioverter-defibrillators
- •History of asthma with active symptomatology in the past year, pulmonary disease or use of inhalers
- •Physical disability, neurological and/or psychological disorder that precludes safe and adequate testing
- •Conditions that may impair the ability to feel pain
- •Mental impairment with limited ability to cooperate
- •Uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, or hyperthyroidism
- •Pregnancy or trying to become pregnant in the next 6 months
- •History of alcohol or drug abuse within the past 6 months as self-reported
- •Suffering from severe depression (with a score >30 in the Beck Depression Inventory)
- •History of unexplained fainting spells as self-reported
- •Head injury resulting in more than a momentary loss of consciousness
- •History of neurosurgery as self-reported
- •Use of antiepileptic and/or hypnotic medications like carbamazepine, valproate acid, gabapentin, zolpidem, etc.
- •Use of medication with potential cardiovascular influence
- •Active smoker, or history of smoking in the last 6 months
- •Skin lesion or open wounds around or in area of electrode application
- •Tattoos in upper limb or along the nerve tract
结局指标
主要结局
VAS
时间窗: Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2)
Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3
DNIC
时间窗: Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2)
Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3
PPT
时间窗: Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2)
Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized).
次要结局
- Heart rate(Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
- Attention Task(Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
- N Back test(Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
- EEG(Visit 2 and Vist 3...where Visit 1 = baseline, Visit 2 = stimulation visit, sham or active (about 2 days from baseline), and Visit 3 = stimulation visit, sham or active (about 1 week from visit 2))
- Time to fatigue(Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
- Perception of physical exertion(Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
- Respiratory rate(Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2))
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital