Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment - Upper Extremity (FMA-UE)
研究概览
简要总结
Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.
详细描述
The Vagal Nerve Stimulation device implantation is a common, standardized neurosurgical procedure that has been performed for over two decades for the treatment of epilepsy and depression and has recently been approved for chronic ischemic stroke. The intended purpose of this registry is to monitor the safety, feasibility, and efficacy of vagal nerve stimulation for stroke recovery. This will be accomplished by monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. The secondary objectives of this study focus on the feasibility and efficacy of employing vagal nerve stimulation for ischemic stroke recovery, as well as obtaining qualitative data on the experience associated with stroke rehabilitation paired with VNS. Additional research questions regarding vagal nerve stimulation for stroke recovery may be addressed as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program
- •Aged 18 or older
- •History of ischemic stroke
- •Upper extremity weakness
- •Planned to undergo VNS implantation
排除标准
- •Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.).
- •Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
研究组 & 干预措施
Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery
Individuals undergoing vagal nerve stimulation (VNS) paired rehabilitation will be included in this cohort.
This is a registry study with no active intervention outside standard of care. Patients with chronic ischemic stroke will be implanted with the Vivistim vagal nerve stimulation device per standard of care.
干预措施: Vivistim (Device)
结局指标
主要结局
Fugl Meyer Assessment - Upper Extremity (FMA-UE)
时间窗: Baseline up to day 390
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index for the upper extremities. It is designed to assess motor functioning in patients with post-stroke hemiplegia of the upper limbs. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total scores range from 0-66, where higher scores indicate better performance.
次要结局
- Action Research Arm Test (ARAT)(Baseline up to day 390)
- Modified Ranking Score (mRS)(Baseline up to day 390)
- Fugl-Meyer Assessment - Lower Extremities (FMA-LE)(Baseline up to day 390)
- Wolf Motor Function Test (WMFT)(Baseline up to day 390)
- National Institutes of Health Stroke Scale (NIHSS)(Baseline up to day 390)
- Stroke Impact Scale (SIS)(Baseline up to day 390)
- Montreal Cognitive Assessment (MoCA)(Baseline up to day 390)
- Patient Reported Outcomes Measurement Information System 29 version 2.1 (PROMIS-29 v2.1) Score(Baseline up to day 390)
- Beck Depression Inventory (BDI)(Baseline up to day 390)
研究者
Christopher P Kellner
Assistant Professor Neurosurgery
Icahn School of Medicine at Mount Sinai