Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Tolerability as assessed by the ability of the participant to complete the treatment protocol
研究概览
简要总结
The purpose of this study is to assess the feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in childhood stroke survivors undergoing bi-manual occupational therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage.
- •Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke)
- •6 months or greater from stroke onset
- •Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm.
- •Affected arm Fugl-Meyer score of 60 or lower.
- •Able to participate in occupational therapy sessions.
排除标准
- •Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation.
- •Presence of cranial metal implants or implant device that could be affected by taVNS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.
结局指标
主要结局
Tolerability as assessed by the ability of the participant to complete the treatment protocol
时间窗: From baseline to end of treatment (5 weeks after baseline)
Tolerability will be assessed by whether the single enrolled participant completes all 12 taVNS-paired occupational therapy sessions and the 1-week post-therapy assessment without withdrawal or a protocol deviation due to tolerability concerns. Completion will be determined using study attendance records, withdrawal documentation, and protocol-deviation records
Change in arm function as assessed by the Fugl-Meyer score of Upper extremity
时间窗: Baseline, 1-week post therapy
Upper extremity motor impairment will be assessed using the therapist-administered Upper Extremity Fugl-Meyer Assessment. The total score ranges from 0 to 66 points, with higher scores indicating better upper extremity motor function.
次要结局
- Change in tolerability as assessed by the number of side effects that occur as documented on the stimulation monitoring sheet(Pre and immediately post stimulation on day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11 and day 12)
研究者
Stuart Mason Fraser
Assistant Professor
The University of Texas Health Science Center, Houston