Randomized Controled Clinical Study to Evaluate the Efficacy of the Increase of the Sensorial Stimuli as a Therapeutic Strategy for the Treatment of Elderly Patients With Oropharyngeal Dysphagia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Oropharyngeal motor response measured by Videofluoroscopy.
研究概览
简要总结
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
Moreover, with an electroencephalographic study we will assess the effect of both treatments in the cortical neuroplasticity.
详细描述
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
The study will last 5 weeks per patient. At the beginning of the study, patients will receive a videofluoroscopic evaluation and an electroencephalography (evoked potentials) to asses dysphagia and cortical activity of deglutition. After that the first day of the third week they will begin the treatment (group a or b) during 2 weeks. Finally in the fifth week an evaluation of dysphagia will be performed the same way as in week 1 to asses the effects of the treatments.
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
- None
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
- •Elderly patients (≥70 years) with oropharyngeal dysphagia (OD)
- •Patients have to fill in and sign the written informed consent.
- •Patients without any of the
排除标准
- •Exclusion Criteria:
- •Patients not able to comply with the protocol.
- •Patients currently participating or having participated in another clinical trial in the last 4 weeks.
- •Patients with active neoplasia.
- •Patients with an active infectious process.
- •Patients with severe dementia or inability to communicate.
- •Patients with pacemakers.
- •Patients with implanted electrodes.
- •Patients with epilepsy or convulsive disorders.
- •Patients with gastroesophageal reflux disease.
结局指标
主要结局
Oropharyngeal motor response measured by Videofluoroscopy.
时间窗: Week 1 and 5.
次要结局
- Cortical activation measured by electroencephalography.(It will be assessed at the beginning and at the end of the study (first and fifth week).)
研究者
Pere Clave
Pere Clavé, MD, PhD
Hospital de Mataró