Effect of Transcranial Direct Current Stimulation Combined With Oral Feeding on Dysphagia: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Penetration Aspiration Scale
研究概览
简要总结
The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
详细描述
Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meet the diagnostic criteria for ischemic stroke;
- •Age > 18 years;
- •First-time stroke;
- •Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
- •Requires enteral nutrition support;
- •Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
- •Transferred to the rehabilitation department within fifteen days of onset; Stable vital signs.
排除标准
- •Presence of contraindications for invasive oral endoscopy;
- •Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
- •Concurrent presence of other neurological disorders;
- •Tracheostomized patients;
- •Concurrent liver, kidney failure, tumor, or hematological disorders;
- •Pregnancy;
- •Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
- •Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.
研究组 & 干预措施
The experimental group
The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
干预措施: Comprehensive rehabilitation therapy (Behavioral)
The experimental group
The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
The experimental group
The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
干预措施: Transcranial direct current stimulation (Device)
The placebo group
The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
干预措施: Comprehensive rehabilitation therapy (Behavioral)
The placebo group
The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
结局指标
主要结局
Penetration Aspiration Scale
时间窗: day 1 and day 15
Penetration-Aspiration Scale is used to measure swallowing safety, which is also the primary outcome of this study. Before and after treatment, patients are required to undergo a swallow study to complete the assessment. This scale evaluates the patient's swallowing function level and aspiration risk by assessing leakage and aspiration during the patient's swallowing process. The results are divided into eight levels, with higher levels indicating poorer swallowing function and lower swallowing safety.
次要结局
- Swallowing Quality of Life Questionnaire(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Nutritional status-total protein(day 1 and day 15)
- Nutritional status-albumin(day 1 and day 15)
- Patient Health Questionnaire-9(day 1 and day 15)
- Body weight(day 1 and day 15)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University