Effect of Non-Invasive Auricular Vagus Nerve Stimulation on the Rehabilitation of Pharyngo-Laryngeal Dysphagia in Patients Over 70 Years Old After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in swallowing function (Gugging Swallowing Screen, GUSS)
研究概览
简要总结
This study investigates the effect of non-invasive transcutaneous auricular vagus nerve stimulation (tVNS-E) on swallowing rehabilitation in patients over 70 years old after stroke. Participants will be randomly assigned to standard speech therapy with either active tVNS-E or a sham device, over four sessions per week for three weeks. Swallowing function and quality of life will be assessed before and after the intervention to evaluate the potential benefit of tVNS-E.
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
- Single (Participant)
盲法说明
Participants do not know if the device is switch on or of
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years.
- •Acute stroke (0-1 month post-stroke).
- •Pharyngo-laryngeal dysphagia (Gugging Swallowing Screen, GUSS: 5/5 on preliminary test and <4/5 on direct test, ignoring the drooling criterion which is not indicative of pharyngo-laryngeal dysphagia).
- •Ability to understand and follow experimental instructions.
- •Signed informed consent.
- •Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke)
排除标准
- •Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion.
- •Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy).
- •Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders).
- •GUSS swallowing test score <5/20 at baseline.
- •Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.
研究组 & 干预措施
active tVNS-E stimulation
Participants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on)
干预措施: tVNS-E active device (Device)
inactive tVNS-E device
Participants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of)
干预措施: tVNS-E inactive device (Device)
结局指标
主要结局
Change in swallowing function (Gugging Swallowing Screen, GUSS)
时间窗: Baseline (T0)
comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function
Change in swallowing function (Gugging Swallowing Screen, GUSS)
时间窗: T2, Day 3 ±2
comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function.
Change in swallowing function (Gugging Swallowing Screen, GUSS)
时间窗: post-intervention (Day 22-24)
comparison of total GUSS scores (ranging from 5 to 20) across the study. Higher scores indicate better swallowing function.
次要结局
- Involuntary cough during swallowing (GUSS sub-item)(Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24))
- Voice change during swallowing (GUSS sub-item)(Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24))
- Swallowing-related quality of life (SWAL-QoL)(Baseline (T0) and post-intervention (T3, Day 22-24))