Efficacy of Transcranial Magnetic Stimulation and Sensory Motor Facilitation versus Sham Transcranial Magnetic Stimulation on Dysphagia Severity, Swallowing Ability, and Quality of Life in subjects with Dysphagia due to Acute Stroke - A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Mann Assessment of Swallowing Ability (MASA)
研究概览
简要总结
Stroke is a leading cause of disability worldwide, and dysphagia (difficulty swallowing) is acommon and debilitating complication. Current treatments for post-stroke dysphagia, such astraditional swallowing therapy, often have limited success.Stoke with severe dysphagia has a devastating impact on quality of life as it can eliminate thepleasure of eating and drinking. It is associated with significant morbidity and mortalityincluding dehydration, malnutrition, airway obstruction, and aspiration pneumonia. Lessrecognized is the impact of dysphagia on psychosocial functions. It can lead to isolation as thepatient withdraws from activities involving food such as family mealtimes, group dinners, andteatime.The earlier studies have focused on either oropharyngeal muscle re-education andstrengthening or non-invasive brain stimulation (NIBS) such as rTMS separately but not in combined form. Sensory motor stimulation and rTMS may work together to enhanceneuroplasticity, promoting the formation of new neural connections and facilitating recoveryof swallowing function. This combined approach may lead to improved clinical outcomes, suchas reduced aspiration risk, improved nutritional status, and enhanced quality of life for strokesurvivors with dysphagia.Hence to find out the effectiveness of rTMS over sham TMS on clinical outcomes in subjectswith dysphagia in acute stroke has to be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects diagnosed with ischemic or haemorrhagic stroke who are in acute phase (2-4 weeks of onset).
- •Presence of dysphagia secondary to stroke, referred by ENT department, Neurology department to neurophysiotherapy department
- •No swallowing disorder attributed to conditions other than stroke.
- •Subjects who are willing to participate in the study 5.Subjects who are conscious, oriented and co-operative.
- •Subjects with GCS scoring more than 12.
排除标准
- •Subjects with recurrent stoke.
- •Subjects with trauma, infections, recently operated.
- •Subjects with on external appliance that is mechanical ventilator, endotracheal tube tracheostomy tube.
- •Subjects with sensory loss, cognitive impairment.
- •Subjects with epilepsy.
- •Subjects with intracranial metallic implants and pacemakers.
- •Hemodynamically unstable subjects.
结局指标
主要结局
1. Mann Assessment of Swallowing Ability (MASA)
时间窗: Baseline to 4weeks
2. Dysphagia Outcome and Severity Scale (DOSS)
时间窗: Baseline to 4weeks
次要结局
- Swallowing Quality of Life (SWAL-QOL) scale(Baseline to 4 weeks)
