Clinical Study on Bilateral High-frequency Repetitive Transcranial Magnetic Stimulation Combined With Swallowing Training for Patients With Dysphagia After Extubation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Oral Intake Scale ，FOIS
研究概览
简要总结
Post-extubation dysphagia (PED) is characterized by a range of clinical manifestations, including absence of visible swallowing effort, coughing or choking following liquid intake, and post-swallowing dysarthria. These impairments may lead to severe complications such as aspiration pneumonia, electrolyte disturbances, and malnutrition. Currently, the majority of hospitals both domestically and internationally have not implemented routine screening for PED or standardized swallowing rehabilitation programs, and research on the recovery of swallowing function in PED remains limited. This study aims to investigate the therapeutic efficacy of bilateral high-frequency repetitive transcranial magnetic stimulation (rTMS) combined with conventional swallowing training in patients with PED, and to evaluate the influence of oral feeding on functional recovery and the incidence of pneumonia.
The study design is a single-center, randomized, single-blind, parallel-controlled trial. Participants with PED will be randomly assigned to either a swallowing training group or a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training group.The primary outcome measure is the Functional Oral Intake Scale (FOIS) score，which assesses oral feeding ability.Secondary outcomes include the Wakada Drinking Water Test(WST),degree of swallowing difficulty(GUSS),the incidence rate of pneumonia and length of stay.These secondary outcomes will provide a comprehensive evaluation of swallowing ability and hospitalization effects.
Random grouping was conducted within 4 hours after extubation, and the treatment began within 2 hours and lasted for 3 consecutive days.Each rTMS session will target key brain regions.Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.The observation group received bilateral high-frequency transcranial magnetic stimulation in addition to the swallowing training.The data will be collected before and after the treatment.The primary outcome, FOIS score, will be used to assess the overall improvement in oral feeding ability.WST and GUSS data will be collected to evaluate a comprehensive evaluation of swallowing ability.The incidence rate of pneumonia and length of stay will be used to assess change in side effects.
Statistical analyses will be performed using SPSS 22.0. Data will be presented as mean ± standard deviation. Between-group differences will be compared using independent samples t-tests.
The study timeline spans from September 2025 to December 2026, including participant recruitment, intervention implementation, data collection, and analysis, as well as manuscript drafting. This study aims to provide new insights into the treatment methods for PED and explore a new rehabilitation approach that can be used in the ICU, with the expectation of improving swallowing disorders and reducing complications.
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)
盲法说明
Blinding After the intervention allocation, the participants and data analysts will be blinded. This is a single - blinded, randomized, parallel - controlled study focusing on rTMS. In the rTMS group, a 20 - minute magnetic stimulation will be applied to the target brain area.. Before the final code - breaking, data analysts won't know the group to which the data they are analyzing belongs.
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
- •Age greater than 18 years;
- •Tracheal intubation for more than 48 hours;
- •Clear consciousness at the time of assessment, able to understand and follow the simple instructions of the researchers;
- •Patients have dysphagia, and the Functional Oral Intake Scale (FOIS) assessment is at levels
排除标准
- •Previous history of dysphagia;
- •Undergoing tracheotomy;
- •History of epilepsy;
- •Having metal implants in the brain;
- •Implanted with a cardiac pacemaker;
- •Under absolute isolation (such as open or infectious pulmonary tuberculosis);
研究组 & 干预措施
Swallowing training plus No intervention
干预措施: No intervention (Other)
a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training
干预措施: Swallowing training (Behavioral)
Swallowing training plus No intervention
干预措施: Swallowing training (Behavioral)
a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training
干预措施: a bilateral high-frequency repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Functional Oral Intake Scale ，FOIS
时间窗: Baseline (before treatment), 3 days after treatment
The oral feeding ability was conducted using the Functional Oral Intake Scale (FOIS), which is divided into 7 levels. The higher the level, the better the oral intake ability.
次要结局
- Wakada Drinking Water Test，WST(Baseline (before treatment), 3 days after treatment)
- degree of swallowing difficulty，GUSS(Baseline (before treatment), 3 days after treatment)
- length of stay(at discharge)
研究者
Qing Shu
associate chief physician
Wuhan University