Effects of Repetitive Transcranial Magnetic Stimulation on Dysphagia in Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
研究概览
简要总结
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. Current project will recruit participants and randomize into two groups.One group will receive NMES, traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. FEES and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.
详细描述
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. The aim of this study is to compare the effects of rTMS, NMES and conventional swallowing therapy to those of sham rTMS, NMES and conventional swallowing therapy. One group will receive NMES, to sham One group will receive NMES,traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. MEP character, FEES, degrees of dysphagia, FOIS, and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset time at least for one week，area not be limited.
- •Patient was first time stroke patient without obvious infection condition.
- •Patients with dysphagia in the stroke who were diagnosed by neurologist and CT/MRI in our institute. Patient was clear with adequate motivation and could cooperate the whole therapy and FEES evaluation.
排除标准
- •Lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation.
- •Mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded.
- •Metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer.
- •Allergy to specific subjects
- •Cognition impairment
- •Alcohol or drugs abuse
- •Afraid of the noise of rTMS.
研究组 & 干预措施
Group A
Conscript 10 individuals, every individual will receive 20 mins of repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.
干预措施: Neuromuscular electrical stimulation combined with conventional swallowing training (Device)
Group A
Conscript 10 individuals, every individual will receive 20 mins of repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Group B
Conscript 10 individuals, every individual will receive sham repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.
干预措施: Neuromuscular electrical stimulation combined with conventional swallowing training (Device)
结局指标
主要结局
Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
时间窗: one day before intervention, 1 day after intervention
In this study, FEES is executed before and after intervention. The assessment of FEES is as follows. Hyodo-score: for predicting aspiration with moderate sensitivity and high specificity. This method consists of four parameters; These four parameters are each scored 0-3 on a 4 point scale (0; normal, 1; mildly impaired, 2; moderately impaired, 3; severely impaired). The Hyodo score is expressed as the sum of scores for each of the four parameters, ranging 0- 12. Patients with a score of less than 5 were assessed as having normal swallowing function. Patients with a score of more than 8 had severe swallowing dysfunction and would not be allowed any oral intake.
Change from baseline in The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) at 2 weeks
时间窗: one day before intervention, 1 day after intervention
The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS): Stroke-related dysphagia was divided into a six-point FEDSS with 1 score for the best and 6 scores for the worst.
Change of baseline Standardized Swallowing Assessment (SSA) at 2 weeks
时间窗: one day before intervention, 1 day after intervention
In this study, SSA was executed before and after intervention. SSA is a standard of universal screening of all stroke patients within 24 hours of admission. And SSA comprises three sections and was designed to terminate if a problem was encountered. The first section checked whether the patient was physically capable of screening; sections 2 and 3 comprised the main screening test. Volitional cough, saliva control, oral motor dexterity, respiratory compromise and phonation were first evaluated; if no problems were elicited, the ability to swallow water was observed.
Change of baseline Latency of Motor evoked potentials (MEP) at 2 weeks
时间窗: one day before intervention, 1 day after intervention
Onset latency of MEP, The latency, however, may provide information about the stress in damaged motor pathways.
Change of baseline Amplitude of Motor evoked potentials (MEP) at 2 weeks
时间窗: one day before intervention, 1 day after intervention.
Onset to peak amplitude of Motor evoked potentials (MEP).The amplitude of motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) is a common yet highly variable measure of corticospinal excitability.
次要结局
- Change of baseline Degree of dysphagia at 2 weeks(one day before intervention, 1 day after intervention)
- Change of Functional Oral Intake Scale (FOIS) at 2 weeks(one day before intervention, 1 day after intervention)
- Change of baseline modified water swallowing test at 2 weeks(one day before intervention, 1 day after intervention)
研究者
Lai chien hung
Professor
Taipei Medical University Hospital