Transcutaneous Auricular Vagus Nerve Stimulation Combined with Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Swallowing function
研究概览
简要总结
The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.
30 patients will be randomized into one of the two arms of the study:
- REAL: real t-VNS + speech therapy
- SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear.
Swallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic or hemorrhagic stroke (within 7 days of onset)
- •Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5
排除标准
- •Pre-existing stroke dysphagia
- •Dementia or other medical conditions that may interfere with the study
研究组 & 干预措施
Real t-VNS
real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
干预措施: Non Invasive vagus nerve stimulation (Device)
Sham t-VNS
sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
干预措施: Non Invasive vagus nerve stimulation (Device)
结局指标
主要结局
Swallowing function
时间窗: Baseline, Immediately after intervention
Swallowing video fluoroscopic will be used to measure swallowing function
次要结局
- Morbidity(Baseline, Immediately after intervention, 3 months after intervention)
- Disability(Baseline, Immediately after intervention, 3 months after intervention)
- Swallowing function(Baseline, 3 months after intervention)
- Mortality(Baseline, Immediately after intervention, 3 months after intervention)
研究者
Di Lazzaro Vincenzo
Prof
Campus Bio-Medico University