Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
研究概览
简要总结
This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS diagnosis, all subtypes
- •Fatigue Severity Scale score of 36 or greater
- •Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver proxy required for those with scores of 7.5 or greater)
- •Ability to understand the informed consent process and provide consent to participate in the study
排除标准
- •Primary neurologic, psychiatric or other medical disorder other than MS
- •History of seizures or seizure disorder
- •History of head trauma or medical device in head or neck
- •Clinically significant abnormality on EKG
- •Current symptomatic treatment for fatigue
- •Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms
- •WRAT-4 reading level below average (<85) (estimated general intellectual function)
- •Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10
- •Current chronic headaches or migraines
- •Skin disorder/sensitive near stimulation locations
结局指标
主要结局
change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
时间窗: 7 Days post end of Treatment
The minimally important difference representing a clinically significant improvement in patient-reported fatigue on the 7-item PROMIS Fatigue Scale is defined as a 3.0 point change in raw score. Clinically-significant response to tDCS treatment by the conservative measurement of \>3.0 points on the PROMIS Fatigue Scale.
次要结局
未报告次要终点