A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- The Modified Barium Swallow Impairment Profile (MBSImP™©)
研究概览
简要总结
This study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to validate the 4ch NMES device.
详细描述
- Design: Prospective study
- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
- Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"
- Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient who do not belong to the criteria excluded for subjects aged 19 years or older
- •Patient who is confirmed to be dysphagia by videofluoroscopy
- •Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
- •Those voluntarily agreeing to the clinical trial
排除标准
- •Patient who refuse inspection, do not agree
- •Simple "Commend obey", first step is impossible
- •When instructions can not be executed due to dementia, psychiatric disorders, etc.
- •Dysphagia occurs due to respiratory failure, neck surgery, etc.,
- •Pregnant women and lactating women
研究组 & 干预措施
Revised sequential activation protocol
Apply 4 channel electrical stimulation device with a revised sequential activation protocol.
It sequentially activates Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device.
干预措施: 4 channel Electrical Stimulation Device (Device)
control subject
Apply 4 channel electrical stimulation device without any stimulation
结局指标
主要结局
The Modified Barium Swallow Impairment Profile (MBSImP™©)
时间窗: Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied
total score 0 from 55, 55 is worst outcome
次要结局
未报告次要终点
研究者
Ju Seok Ryu
associate professor
Seoul National University Hospital