Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
研究概览
简要总结
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
详细描述
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged >18 years
- •Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
- •Fatigue severity score average >4 (severe fatigue)
- •Willingness to remain stable on pharmacologic therapy through the duration of the study.
- •Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.
排除标准
- •Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
- •History of seizure
- •History of moderate to severe traumatic brain injury
- •A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
- •A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
- •Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
- •Inability to provide informed consent
- •Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
结局指标
主要结局
Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
时间窗: Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity.
次要结局
- Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)(Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Mean change from baseline PROMIS-sleep disturbance(Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Mean change from baseline Symbol Digit Modalities Test (SDMT)(Baseline (Day 1), Post-Treatment (Day 14-21))
- Mean change from baseline Test of Variables of Attention (T.O.V.A)(Baseline (Day 1), Post-Treatment (Day 14-21))
- Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)(Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Mean change from baseline Frenchay activities index(Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)(Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Mean change from baseline Montreal cognitive assessment (MoCA)(Baseline (Day 1), Post-Treatment (Day 14-21))
- Mean Client Satisfaction Questionnaire - 8 (CSQ-8)(During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
- Change in resting state brain functional connectivity.(Baseline (Day 1), Post-treatment (Day 14-21))