Effects of tDCS on Post-stroke Fatigue and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Fatigue Severity Scale (FSS) Score
研究概览
简要总结
Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of any race or ethnicity
- •35-80 years of age
- •6+ months post-stroke
- •Have clinically present fatigue for 6 months
- •Able to walk 10m unassisted
排除标准
- •Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)
- •Inability to understand and provide written informed consent
- •Multiple strokes on opposite hemispheres
- •Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia)
- •Severe hypertension
- •Cerebellar or brainstem strokes/lesions
- •Concurrent depression and/or anxiety disorders
研究组 & 干预措施
Real
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
干预措施: anodal transcranial direct current stimulation (a-tDCS) (Device)
Sham
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
干预措施: sham stimulation (Device)
结局指标
主要结局
Change in Fatigue Severity Scale (FSS) Score
时间窗: Baseline, post-intervention (2-weeks)
Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue
次要结局
- Change in Fatigue Assessment Scale (FAS)(Baseline, post-intervention (2-weeks))
研究者
John H Kindred
Principle Investigator
Medical University of South Carolina