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临床试验/NCT02893033
NCT02893033已完成不适用

Neuromodulation With rTMS in Dysphagic Patients With Stroke

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 5 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
主要终点
functional outcome

研究概览

简要总结

The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy,2.Functional outcome swallowing scale (3 scales). 3. MEP measurements

详细描述

While the reflex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.

In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •a diagnosis of stroke related dysphagia
  • •no concurrent neurodegenerative or dementia history
  • •an absence of TMS contraindications.

排除标准

  • •arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt

研究组 & 干预措施

Real stimulation

Experimental

Real repetitive transcranial magnetic stimulation + swallowing training

干预措施: repetitive transcranial magnetic stimulation (Device)

Sham stimulation

Sham Comparator

Sham repetitive transcranial magnetic stimulation + swallowing training

干预措施: repetitive transcranial magnetic stimulation (Device)

结局指标

主要结局

functional outcome

时间窗: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist

次要结局

  • videofluoroscopy(prior to treatment (baseline), on the next day after the 2 weeks treatment completion)
  • cricopharyngeal motor evoked potentials(prior to treatment (baseline), on the next day after the 2 weeks treatment completion)

研究者

申办方类型
Other Gov
责任方
Sponsor

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