Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Variation in motor evoked potential amplitude
研究概览
简要总结
Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It involves many brain areas, including primary motor and sensory areas. Its dysfunction, called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this case, it is conventionally translated by a swallow response time delay of the swallowing reflex.
Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery appear to be related to a reorganization of the motor cortex intact. Patients who retain disorders are those who have not cortical reorganization.
With this in mind a team used different methods known to modulate brain plasticity, which electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation increases the excitability of the cortico- bulbar reflex, which improves swallowing function in the clinical application.
The hypothesis of this work is that the transcutaneous electrical stimulation applied submental, noninvasive technique, would also have an impact on cortical plasticity may explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) ( Gallas , 2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged over 18 years
- •Affilitation to social security scheme
- •Registration in National register of people who participate in biomedical research
- •Healthy volunteers who provided written informed consent
排除标准
- •Subjects with swallowing disorders
- •Presence of psychiatric disorders
- •Skin disorders
- •Cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve)
- •Submental tumor
- •Epilepsia, treated or untreated
- •Presence of neurosurgical clip
- •Suspicion of digestive fistula
- •Presence of metal, pacemaker, defibrillator, pump treatment or neurostimulation
- •Cannabis user, regular use of benzodiazepines
- •Presence of chronic respiratory, neurological disease, ENT or gastroesophageal disease (cause potentially change swallowing)
- •Contra-indication to MRI (claustrophobia, metal fragment, cardiac/ENT/neurological implantable device not MRI compatible, osteosynthesis prior to 1980)
- •Subject reported against the use of Micropaque®
- •Pregnant or nursing woman, or absence of contraception
- •Poor understanding of French langage
- •Person under judicial protection
- •Person deprive of their liberty by judicial or administrative decision
- •Participating in a clinical trial within 4 weeks before the pre-inclusion visit
研究组 & 干预措施
submental sensitive transcutaneous electrical stimulation.
Each Healthy subjects will be his own witness. Urostim 2 stimulation Arm
干预措施: Urostim 2 stimulation (Device)
结局指标
主要结局
Variation in motor evoked potential amplitude
时间窗: 1 month
Our aim was to show that submental sensitive transcutaneous electrical stimulation (SSTES) can modified swallowing function. Primary endpoint is change in motor evoked potential amplitude after submental transcutaneous electrical stimulation
次要结局
- variation of swallow reaction time(1 Month)