Neuromodulation for Functional Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment.
研究概览
简要总结
This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group.
This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.
详细描述
This study uses a multicenter, double-blind, randomized controlled design. Eligible participants all undergo implantation of a VNS device and are randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. The study hypothesizes that vagus nerve stimulation is effective in improving upper limb motor function in patients in the subacute phase after stroke; that is, a meaningful difference in FMA-UE scores exists between the active VNS group and the control group at the end of 6 weeks of hospital treatment. All enrolled participants undergo implantation of a vagus nerve stimulation device. After preoperative assessment, patients undergo implantation of the vagus nerve stimulation device under general anesthesia. After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). This trial uses the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity, with a pretreatment baseline assessment performed 1 week after implantation. Stimulation testing is performed in 0.1 mA increments in both groups to assess the level at which participants can perceive and tolerate stimulation. Hospital treatment begins on the day after baseline assessment.
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, Care Provider)
盲法说明
Double-blind: participant-blinded and care provider-blinded. Participants' prognostic information was recorded in detail by two physicians blinded to treatment assignment during the hospital treatment period and at 1, 30, and 90 days after hospital treatment.
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
- •History of unilateral supratentorial ischemic stroke and in the subacute phase (3-6 months);
- •Age between 18-80 years, both male and female;
- •FMA-UE score of 20-50 (inclusive);
- •Ability to communicate, understand, and provide appropriate consent; participant can follow two-step commands;
- •Right or left upper limb weakness;
- •Active flexion/extension of the wrist or fingers;
- •Informed consent signed by the patient or a family member.
排除标准
- •History of hemorrhagic stroke;
- •Persistent dysphagia or choking/coughing while eating or drinking;
- •Medications that, at study initiation, may significantly interfere with the effects of VNS on neurotransmitter systems;
- •Prior vagus nerve injury, bilateral or unilateral (e.g., injury during carotid endarterectomy);
- •Severe or more severe depression (Beck Depression Inventory >29);
- •Candidates unsuitable for device implantation surgery (e.g., history of adverse reaction to anesthesia, deemed unsuitable as a surgical candidate by the surgeon, etc.);
- •Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug;
- •Preexisting neurological or psychiatric disorders before stroke onset that affect assessment of the condition;
- •Pregnancy, planned pregnancy, or breastfeeding during the study period;
- •Severe upper limb spasticity (modified Ashworth ≥3);
- •Severe sensory loss. Sensory loss will be measured using the upper extremity sensory portion of the Fugl-Meyer Assessment. The assessment involves light touch (two items) and proprioception (four items). The maximum score is 12; subjects with a score below 6 will be excluded from the study;
- •Other conditions that the investigator considers unsuitable for participation or that may pose a significant risk to the patient.
研究组 & 干预措施
Active VNS group
After implantation, participants randomized to active VNS (0.8 mA) combined with upper limb rehabilitation.
干预措施: active VNS (0.8 mA) (Other)
Control VNS group
After implantation, participants randomized to control VNS (0 mA) combined with upper limb rehabilitation.
干预措施: Control VNS (0.0 mA) (Other)
结局指标
主要结局
The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment.
时间窗: At the end of 6 weeks of hospital treatment.
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
次要结局
- Clinically meaningful improvement in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days (≥6-point improvement in FMA-UE score);(90 days)
- Change from baseline in Wolf Motor Function Test (WMFT) score at 90 days(90 days)
- Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days(90 days)