Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Change in Upper Extremity Fugl-Meyer (UEFM)
研究概览
简要总结
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
- •Age >30 years and <80 years
- •Right or left sided weakness of upper extremity
- •UEFM score within designated range.
- •At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits
排除标准
- •History of hemorrhagic stroke
- •Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
- •Significant sensory loss.
- •Presence of ongoing dysphagia or aspiration difficulties.
- •Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
- •Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
- •Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
- •Severe depression
- •Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
- •Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
- •Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
- •Pregnant or plan on becoming pregnant or breastfeeding during the study period
- •Currently require, or likely to require, diathermy during the study duration
- •Any health problem requiring surveillance with MRI imaging
- •Active rehabilitation within 4-weeks prior to therapy
- •Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
- •Severe spasticity of the upper limb
研究组 & 干预措施
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
干预措施: Vagus Nerve Stimulation (VNS) (Device)
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
干预措施: Vagus Nerve Stimulation (VNS) (Device)
结局指标
主要结局
Change in Upper Extremity Fugl-Meyer (UEFM)
时间窗: 6-weeks
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
次要结局
- Change in Wolf Motor Function Test Functional Assessment (WMFT)(6-weeks)