Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity)
研究概览
简要总结
The aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years, with motor impairment in the upper extremity caused by unilateral ischemic or hemorrhagic stroke with stroke onset within the last five years.
排除标准
- •Patients with any contraindication to taVNS, peripheral upper extremity injuries, use of medication affecting cortical excitability in the past 3 months, use of botulinum toxin in the past 3 months, presence of any other neurological disorder, or significant cognitive deficits.
研究组 & 干预措施
Active transcutaneous vagus nerve stimulation stimulation (taVNS)
干预措施: Active taVNS (Device)
Sham transcutaneous vagus nerve stimulation stimulation (s-tAVNS)
干预措施: Sham taVNS (Device)
结局指标
主要结局
Upper extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity)
时间窗: Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10)
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor impairment and recovery of the paretic upper extremity. It consists of items from sections III and IV, assessing motor function, coordination, and speed, with a maximum score of 66 points. Higher scores indicate lower motor impairment. A minimal clinically important difference (mCID) is defined as a change (Δ) of 5 or more points between baseline and post-intervention scores.
次要结局
- Global Perception of Change (Patient Global Impression of Change)(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10))
- Health-Related Quality of Life (Stroke-Specific Quality of Life Scale)(Baseline (day 0), mid-intervention (day 5), post-intervention (day 10))
- Multidimensional Stroke Impact (Stroke Impact Scale)(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10))
- Manual Dexterity (Box and Block Test)(Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10))
- Independence (Functional Independence Measure)(Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10))
- Spasticity (Modified Ashworth Scale)(Baseline (Day 0), mid-intervention (day 5) and post-intervention (day 10))
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco