Augmenting Cerebral Perfusion With Transcranial Direct Current Stimulation (tDCS) in Chronic Hypoperfusion States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Changes in cerebral blood flow
研究概览
简要总结
This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •Vasculopathy leading to imaging evidence of hypoperfusion
- •Cognitive impairment
排除标准
- •Pregnancy
- •Contraindication to MRI or 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.
研究组 & 干预措施
Phase II Sham Stimulation, Then Active Stimulation
Subjects first receive sham tDCS plus cognitive training daily for 10 days. After a washout period of 4 weeks, they will perform at-home active tDCS plus cognitive training daily for 10 days.
干预措施: Soterix® 1x1 tDCS (Device)
Phase II Sham Stimulation, Then Active Stimulation
Subjects first receive sham tDCS plus cognitive training daily for 10 days. After a washout period of 4 weeks, they will perform at-home active tDCS plus cognitive training daily for 10 days.
干预措施: Cognitive training program (Behavioral)
Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation
Healthy subjects will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
干预措施: Soterix® 4x1HD-TDCS (Device)
Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation
Healthy subjects will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
干预措施: Soterix® 4x1HD-TDCS (Device)
Phase I Disease Group: Active Stimulation, Then Sham Stimulation
Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
干预措施: Soterix® 4x1HD-TDCS (Device)
Phase I Disease Group: Sham Stimulation, Then Active Stimulation
Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.
干预措施: Soterix® 4x1HD-TDCS (Device)
Phase II Active Stimulation, Then Sham Stimulation
Subjects first receive active tDCS plus cognitive training every weekday for 10 days. After washout period of 4 weeks, they will perform at-home sham tDCS plus cognitive training every weekday for 10 days.
干预措施: Soterix® 1x1 tDCS (Device)
Phase II Active Stimulation, Then Sham Stimulation
Subjects first receive active tDCS plus cognitive training every weekday for 10 days. After washout period of 4 weeks, they will perform at-home sham tDCS plus cognitive training every weekday for 10 days.
干预措施: Cognitive training program (Behavioral)
结局指标
主要结局
Changes in cerebral blood flow
时间窗: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58
Cerebral blood flow imaging assessed by MRI to measure blood flow through the blood vessels reported in millimeters of mercury (mmHg)
次要结局
- Change in trail making test(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in memory task(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in cognitive impairment(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in Stroke Specific Quality of Life (SS-QOL)(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in depression severity(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in sleepiness(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in Fatigue Severity Scale (FFS)(Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)
- Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)(Phase I Day 0, Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14)