Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Dysphagia severity as measured by FEES
研究概览
简要总结
The purpose of the study is to examine the effectiveness of different methods for the treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from PD develop dysphagia during the course of their disease leading to malnutrition, loss of life quality, weight loss and pneumonia, which is the leading cause of death in these patients. So far, only a few specific treatment approaches have been investigated in PD patients with swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing processing the investigators apply magnetoencephalography (MEG).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn & Yahr stages II-IV
- •Parkinson-related dysphagia
- •Oral nutrition
- •Ambulant setting
- •No change of medication for at least 4 weeks before study inclusion
排除标准
- •Other causes for dysphagia
- •Other neurological disease potentially causing dysphagia
- •Dementia (MMSE<25; Montreal cognitive assessment (MoCA)<26)
- •Severe depression (BDI>19)
- •Percutaneous endoscopic gastrostomy (PEG)
研究组 & 干预措施
EMST and sham-TMS
Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation
干预措施: Expiratory muscle strength training (EMST) (Device)
EMST and sham-TMS
Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation
干预措施: Transcranial magnetic stimulation (TMS) (Other)
sham-EMST and TMS
Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation
干预措施: Expiratory muscle strength training (EMST) (Device)
sham-EMST and TMS
Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation
干预措施: Transcranial magnetic stimulation (TMS) (Other)
EMST and TMS
Active expiratory muscle strength training in combination with active transcranial magnetic stimulation
干预措施: Expiratory muscle strength training (EMST) (Device)
EMST and TMS
Active expiratory muscle strength training in combination with active transcranial magnetic stimulation
干预措施: Transcranial magnetic stimulation (TMS) (Other)
sham-EMST and sham-TMS
Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation
干预措施: Expiratory muscle strength training (EMST) (Device)
sham-EMST and sham-TMS
Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation
干预措施: Transcranial magnetic stimulation (TMS) (Other)
结局指标
主要结局
Dysphagia severity as measured by FEES
时间窗: Four weeks
次要结局
- Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)(Four weeks and three months)
- Dysphagia severity as measured by FEES(Three month)
- Cortical reorganization of swallowing process as detected by MEG(Four weeks and three month)