The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FM-UE scores between cerebellar DBS and VNS
研究概览
简要总结
Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery.
- •Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
- •Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).
排除标准
- •Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
- •Severe cognitive impairment (Mini Mental State Examination < 24)
研究组 & 干预措施
Bilateral Cerebellar deep brain stimulation
Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated bilaterally.
干预措施: Bilateral Cerebellar deep brain stimulation (Device)
Unilateral Cerebellar deep brain stimulation
Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated unilaterally.
干预措施: Unilateral Cerebellar deep brain stimulation (Device)
Vagus Nerve Stimulation
Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system. 1 months later, VNS was activated unilaterally.
干预措施: Vagus Nerve Stimulation (Device)
结局指标
主要结局
FM-UE scores between cerebellar DBS and VNS
时间窗: 12 months after device implantation
The outcomes includes each participant's Fugl-Meyer assessment scale (FM-UE) scores for each monthly visit. FM-UE scores range from 0 to 100 and the higher scores indicated better outcome of movement.
次要结局
- Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS(12 months after device implantation)
- the Nine-Hole Peg Test between cerebellar DBS and VNS(12 months after device implantation)
- the Bilateral Box and Block Test between cerebellar DBS and VNS(12 months after device implantation)
- Short Form Health Survey (SF-12) between cerebellar DBS and VNS(12 months after device implantation)
- the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS(12 months after device implantation)
- the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS(12 months after device implantation)
- nerve conduction velocity between cerebellar DBS and VNS(12 months after device implantation)
- safety and feasibility of VNS and cerebellar DBS(12 months after device implantation)