NCT07394608招募中不适用
Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of adverse event and serious adverse events
研究概览
简要总结
This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 years old
- •Diagnosis of spastic cerebral palsy
- •Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)
- •Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)
- •Ability to communicate and follow two step commands at the time of screening
- •Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent
排除标准
- •Previous vagus nerve injury
- •Less than 12 years old or greater than 18 years old
- •History of left or bilateral vagotomy
- •Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.
- •Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:
- •Acute suicidal thinking or behavior
- •History of schizophrenia, schizoaffective disorder, or delusional disorders
- •History of rapid cycling bipolar disorder
- •Progressive neurological diseases
- •Cardiac arrhythmias or other abnormalities
- •History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.
- •GMFCS score of less than II or greater than III (will be evaluated at screening)
- •Jebsen Taylor Hand Function Test Score of >37.08 on the affected side at time of screening visit (will be evaluated at screening)
研究组 & 干预措施
Non-invasive VNS
Experimental
Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions
干预措施: Non-invasive taVNS (Device)
结局指标
主要结局
Number of adverse event and serious adverse events
时间窗: 12 months
Safety is assessed by adverse event.
次要结局
- Number of therapy sessions complete(end of therapy visits at Day 46)
- Active training time per session(end of therapy visits at Day 46)
- Number of movement repetitions completed per session(end of therapy visits at Day 46)
- Jebsen Taylor Hand Function Test (JTHFT)(baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months)
- BOT-2(baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months)
- ABILHANDS(baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months)
- Pediatric Evaluation of Disability (PEDI)(at 12 months)
- Pediatric Quality of Life Inventory (PedsQL)(baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months)
研究者
David Putrino
Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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