Non-invasive Vagus Nerve Stimulation for Language Recovery in Aphasia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The goal of this research study is to evaluate a novel approach to improving speech recovery in those with acquired apraxia of speech. We will enroll participants with apraxia of speech resulting from stroke or brain injury to complete several tasks and intervention. Testing will take place four times over the course of the study and intervention will take place 5 days a week for 16 weeks. Overall, you can expect to spend up to 17 weeks participating in this study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18-80
- •Native speakers of English or simultaneous bilinguals
- •At least 6 months post stroke or TBI
- •Diagnosed production type aphasia or apraxia of speech
排除标准
- •Additional cognitive or neurological impairments (Autism, schizophrenia, seizures, etc)
- •Language comprehension deficits
- •Medications that influence key neurotransmitters
研究组 & 干预措施
Treatment A
non-invasive vagus nerve stimulation is administered alongside standard intervention
干预措施: taVNS (Device)
Treatment B
sham stimulation is administered alongside standard intervention
干预措施: sham taVNS (Device)
结局指标
主要结局
Adverse events
时间窗: 6 months
Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.
Compliance
时间窗: 6 months
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
次要结局
- Change in speech production scores(6 months)