Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Functional Oral Intake Scale (FOIS)
研究概览
简要总结
Ischemic stroke is a common clinical disease, often accompanied by dysphagia. At present, clinical treatment for patients with dysphagia after ischemic stroke is limited. The emergence of NGF has surprised the field of neurorehabilitation, but the clinical effect is not satisfactory. The main problem is that NGF is a macromolecular material with a molecular weight of 13.4 KD, which is difficult to penetrate the blood brain barrier. A large number of previous studies in our team have found that electroacupuncture with specific stimulation mode can open the blood brain barrier and induce NGF into the brain. Therefore, the purpose of this study is to investigate the effect of specific mode electroacupuncture stimulation combined with NGF treatment on patients with dysphagia after ischemic stroke and to explore the mechanism of this combination therapy to improve brain function, which creates a new method and theoretical basis for nerve rehabilitation of integrated traditional Chinese and Western medicine.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with first-ever ischemic stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI);
- •Onset time ranged from 15 days to 180 days;
- •Aged 18 to 80 years old, male or female;
- •Dysphagia confirmed by a videofluoroscopic swallowing study (VFSS);
- •Patients who are able to accept and comply with acupuncture, electroacupuncture treatment, gluteal intramuscular injection, and have good compliance;
- •Have provided signed consent and exhibit willingness to participate in the trial.
- •Women who are lactating, pregnant or intending to get pregnant;
排除标准
- •Patients with dysphagia before ischemic stroke onset or dysphagia not caused by ischemic stroke;
- •Patients with severe cognitive impairment;
- •Patients with severe cardiac, hepatic, and renal dysfunction, as well as severe coagulation abnormalities;
- •Patients with other abnormal test results who are deemed unsuitable to participate in this study by the investigator.
- •Multiple occurrences of stroke, or a history of craniocerebral surgery, or cerebral infarction caused by trauma or brain tumors.
- •Patients with severe neurological deficits prior to ischemic stroke, such as visual and auditory impairments, aphasia, agnosia, severe hemiplegia, and other conditions.
- •Women who are lactating, pregnant or intending to get pregnant;
- •Patients with a history of needle fainting or with skin infections at the acupuncture site.
- •Cardiac pacemaker carrier;
- •Patients allergic to NGF;
- •The inability to undergo VFSS;
- •Patients with a medication history that may alter cortical excitability within the past 2 months.
- •Patients who are currently participating in other clinical trials or have participated in clinical trials that ended within the last 3 months.
研究组 & 干预措施
EA + NGF group
干预措施: Nerver growth factor (NGF) injection (Drug)
EA + NGF group
干预措施: EA intervention (Device)
EA + placebo group
干预措施: Placebo injection (Drug)
EA + placebo group
干预措施: EA intervention (Device)
Acupuncture + NGF group
干预措施: Nerver growth factor (NGF) injection (Drug)
Acupuncture + NGF group
干预措施: Acupuncture intervention (Device)
Acupuncture + placebo group
干预措施: Placebo injection (Drug)
Acupuncture + placebo group
干预措施: Acupuncture intervention (Device)
结局指标
主要结局
Functional Oral Intake Scale (FOIS)
时间窗: week 0, week 2, week 4, week 6, week 12
次要结局
- Dysphagia Outcome and Severity Scale (DOSS)(week 0, week 6)
- Penetration Aspiration Scale (PAS)(week 0, week 6)
- modified Rankin Scale (mRS)(week 0, week 2, week 4, week 6)
- Modified Barthel Index (MBI)(week 0, week 2, week 4, week 6)
- Oxygenated hemoglobin and deoxygenated hemoglobin in cerebral cortex(week 0, week 6)
研究者
Xianming Lin
PHD
The Third Affiliated hospital of Zhejiang Chinese Medical University