Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Evaluation of oropharyngeal dysphagia symptoms
研究概览
简要总结
Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.
The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.
Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.
We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •No contraindication to electrical stimulation
- •Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale > 3 or a residue ≥ 50%
- •Due to an hemispheric stroke
- •Patients able to understand the videofluroscopy and questionnaires
- •For women in age of procreation, to have a contraception, a pregnacy test will be done if not
- •Able to swallow (a nasogastric tube is not a contraindication to participate)
排除标准
- •Pregnancy or breast feeding
- •Psychiatric illnes
- •Swallowing disorders before the stroke
- •Contraindication to electrical stimulation
结局指标
主要结局
Evaluation of oropharyngeal dysphagia symptoms
时间窗: Week 6
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)
次要结局
- Evaluation of oropharyngeal dysphagia symptoms(Week 6)