Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Penetration Aspiration Scale (PAS) Score
研究概览
简要总结
During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged brain structures. There is evidence of a positive effect of PES in Stroke and Multiple Sclerosis patients.
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 (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
- •possible, probable or definite ALS according to the revised El Escorial criteria (Brooks et al. 2000)
- •age >18 years
- •able to understand all information and to give full consent according to good clinical practice (GCP)
- •moderate ot severe dysphagia, defined by a mean value (all consistencies) of 4
排除标准
- •concurrent participation in another interventional trial
- •tracheostomy
- •severe psychiatric disorder or clinically manifest dementia
- •pulmonal or cardial disorder which constitutes a risk when inserting the tube into the pharynx
- •permanent cardiac pacemaker or defibrillator
结局指标
主要结局
Penetration Aspiration Scale (PAS) Score
时间窗: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)
次要结局
- Swallowing-Quality of Life Score (SWAL-QOL)(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Functional Oral Intake Scale (FOIS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Schluckbeeinträchtigungs-Skala (SBS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Dysphagia Severity Rating Scale (DSRS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Frequency of Adverse Events(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
研究者
Albert Christian Ludolph, Prof.
Prof.
University of Ulm