Enhancing Functional Recovery With Home-based Transcranial Direct Current Stimulation (tDCS) in Patients With Stroke, Neurodegeneration and Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test
研究概览
简要总结
The purpose of this study is to assess the feasibility of home-based Transcranial Direct Current Stimulation (tDCS) combined with a home activity based therapy program in patients with stroke, brain tumors or neurodegenerative conditions and to assess the efficacy of home-based tDCS combined with a home activity-based therapy program as an intervention to treat cognitive-linguistic impairments related to stroke, brain tumors, or neurodegenerative conditions and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •At least 3 months after ischemic/hemorrhagic/anoxic stroke or 3 months after completion of cranial radiation or cranial surgery for treatment of primary or metastatic intracranial tumors or neurodegenerative conditions include, but are not limited to, primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, and Alzheimer's disease dementia.
- •Expected survival >6 months
- •Functional impairment in the domains of language and/or cognition affecting quality of life determined by PI.
- •Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).
- •Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).
排除标准
- •Pregnancy
- •Contraindication to tDCS, including metallic implanted objects.
- •Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
- •Individuals with epilepsy
研究组 & 干预措施
Home-Based Treatment: Active Stimulation, Then Sham Stimulation
Subjects will first receive active tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based sham treatment arm after a 4-8-week washout period.
干预措施: Soterix® tDCS - Home treatment (Device)
Home-Based Treatment: Sham Stimulation, Then Active Stimulation
Subjects will first receive sham tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based active treatment arm after a 4-8-week washout period.
干预措施: Soterix® tDCS - Home treatment (Device)
Home-Based Treatment: Sham Stimulation, Then Active Stimulation
Subjects will first receive sham tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based active treatment arm after a 4-8-week washout period.
干预措施: Cognitive-linguistic therapy (Behavioral)
Lab-Based Treatment: Active Stimulation, Then Sham Stimulation
Subjects will be seen in person to first receive active tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based sham treatment arm after an 8 week washout period.
干预措施: Soterix® tDCS - Lab treatment (Device)
Lab-Based Treatment: Sham Stimulation, Then Active Stimulation
Subjects will be seen in person to first receive sham tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based active treatment arm after an 8 week washout period.
干预措施: Soterix® tDCS - Lab treatment (Device)
Home-Based Treatment: Active Stimulation, Then Sham Stimulation
Subjects will first receive active tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based sham treatment arm after a 4-8-week washout period.
干预措施: Cognitive-linguistic therapy (Behavioral)
结局指标
主要结局
For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test
时间窗: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks
The Stricker Learning Span (SLS) is a computer-adaptive digital word list memory test specifically designed for remote assessment and self-administration on a web-based multi-device platform (Mayo Test Drive).
For patients with post-stroke language impairment--Mayo-developed web-based language
时间窗: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks
The exam includes a standard protocol including sentence and word repetition, standard reading passage, vowel prolongation, speech alternating motion rates , sequential motion rates, picture description, naming, and animal fluency
次要结局
- Communicative Participation Item Bank(Baseline, 12 weeks, 24 weeks)
- For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version(Baseline, 12 weeks, 24 weeks)
- Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)(Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks)
- Change in Epworth Sleepiness Scale (ESS)(Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks)
- Karolinska Sleepiness Scale (KSS)(10 minutes before and after each treatment session)
研究者
Rene L. Utianski
Principal Investigator
Mayo Clinic