Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events [Device Safety]
研究概览
简要总结
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Adult, aged 22-79
- •Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
- •UEFM score of 20 to 50
- •Modified Rankin Score of 2, 3, or 4
- •Right vocal cord has normal movement when assessed by laryngoscopy
- •Women of reproductive potential must use contraceptive protection
- •Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Deficits in language or attention that interfere with study participation
- •Severe spasticity (Modified Ashworth ≥ 3)
- •Medical or mental instability that would likely interfere with study protocol
- •Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
- •Presence of any other implanted electrical stimulation device
- •Prior injury to vagus nerve
- •Lactating, pregnant, or plan to become pregnant
- •Participation in another interventional clinical trial
- •Clinical complications that hinder or contraindicate the surgical procedure
- •Abusive use of alcohol and/or illegal substances use
- •Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
- •Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
- •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- •Recent history of syncope
- •Recent history of dysphagia
- •Current or anticipated requirement for diathermy
- •Uncontrolled hypertension
- •Diagnosed with Cerebral amyloid angiopathy
研究组 & 干预措施
Immediate Start Vagus Nerve Stimulation group
The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
干预措施: Active Vagus Nerve Stimulation (Device)
Delayed Start Vagus Nerve Stimulation group
The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
干预措施: Placebo Vagus Nerve Stimulation (Device)
Follow-On Study Group
The Follow-On Study group will receive up to 112 rehabilitation sessions with active VNS over the course of approximately 36 weeks after completion of Phase II. Participants will be provided with a system of rehabilitative devices to utilize at home.
干预措施: Active Vagus Nerve Stimulation (Device)
结局指标
主要结局
Incidence of Adverse Events [Device Safety]
时间窗: From Week 1 through study follow-up, approximately two years after the implant date or final session of rehabilitation (whichever comes second)
Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis
次要结局
- Modified Rankin Scale(Weeks 1, 5, 12, 19, 20, 24, 32)
- Action Research Arm Test(Weeks 1, 5, 12, 19, 20, 24, 32)
- ReStore Stimulation Successes(Weeks 6-11, during follow-on intervention visits 2-13, 14-25, and 25-36)
- Upper-Extremity Fugl-Meyer Assessment (UEFM)(Weeks 1, 3, 10, 17)
- Wolf Motor Task Functional Ability Scale(Weeks 1, 3, 10, 17)
- Quantitative Force and Range of Motion Assessment(Weeks 1, 3, 10, 17)