Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Upper extremity motor impairment
研究概览
简要总结
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
详细描述
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
- •Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
- •Age ≥ 18;
- •Able to provide written informed consent.
排除标准
- •Implanted electronic device (e.g., pacemaker, neurostimulator);
- •Pregnancy;
- •Major psychiatric or medical condition that could interfere with study participation;
- •Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
- •Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5);
- •History of seizure during year before stroke or > 1 post-stroke seizure;
- •Significant cognitive or language impairment that would interfere with informed consent or study participation;
- •Severe dysphagia;
- •Bradycardia defined as resting heart rate < 50 bpm;
- •Nonsustained ventricular tachycardia;
- •Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
- •History of asystole;
- •History of recurrent vaso-vagal syncope;
- •Hypotension defined as blood pressure < 90/60 mmHg.
结局指标
主要结局
Upper extremity motor impairment
时间窗: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
次要结局
- Upper extremity motor function(Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke)
- Grip force control(Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke)
- Upper extremity disability(Baseline to 3 months post-stroke)
- Mood state, anxiety and depression(Baseline to 3 months post-stroke)
研究者
Judith Schaechter
Assistant Professor, Department of Radiology, Harvard Medical School
Massachusetts General Hospital