Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Videofluoroscopy
研究概览
简要总结
This study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to Parkinson's Disease
详细描述
The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment will be given and the effects will be assessed with a barium exam called videofluoroscopy within the 1st hour after the treatment. In addition, some measures of brain function will be recorded, before and after the treatments using single pulse transcranial magnetic stimulation.
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)
盲法说明
Patient blinding
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
- •Confirmed Parkinson's Disease with dysphagia
排除标准
- •Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent
研究组 & 干预措施
Pharyngeal stimulation
Pharyngeal stimulation given at 5Hz for 10 minutes
干预措施: repetitive magnetic stimulation (Device)
repetitive magnetic stimulation (1Hz)
repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
干预措施: repetitive magnetic stimulation (Device)
repetitive magnetic stimulation (5Hz)
repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
干预措施: repetitive magnetic stimulation (Device)
Sham treatment
Sham repetitive transcranial magnetic stimulation using the coil tilt technique
干预措施: repetitive magnetic stimulation (Device)
结局指标
主要结局
Videofluoroscopy
时间窗: 1 hour
Changes in penetration aspiration scale
次要结局
- Brain excitability(Immediately after, 30 and 60 minutes)
研究者
Prof Shaheen Hamdy PhD FRCP
Professor of Neurogastroenterology
University of Manchester