Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity
研究概览
简要总结
In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.
详细描述
This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of subacute-chronic ischemic stroke (3-12 months)
排除标准
- •Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
- •Severe depression (Beck Depression Scale > 29)
- •Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
- •Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
- •Pregnancy or planning to become pregnant or breastfeed during the study period.
- •Botox injections or hemiplegia rehabilitation within 6 months before treatment.
- •Having a history of hemorrhagic stroke
- •Presence of ongoing dysphagia or aspiration difficulties.
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity
时间窗: Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks
It is considered as gold standard and is the only impairment level measure recommended for stroke trials. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Stroke-Specific Quality of Life Scale
时间窗: Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks
The Stroke-Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. 49 questions under 12 subscales. Scores range from 49-245. Higher scores indicate better functioning.
次要结局
- Barthel Index(Change from Baseline Barthel Index at 4 weeks and 12 weeks)
- Berg Balance Test(Change from Baseline Berg Balance Test at 4 weeks and 12 weeks)
- Modified Ashworth Scale(Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks)
- Composite Autonomic Symptom Score (COMPASS-31)(Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks)
- Pittsburgh Sleep Quality Index(Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks)