Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.
详细描述
Transcutaneous, or non-invasive, spinal cord stimulation (tSCS) has been effective at improving motor control, especially walking, in adults with a variety of neuromuscular disorders and in children with spinal cord injury. Children with spina bifida often have similar difficulties with walking, muscle strength and bladder control throughout their lives, with few effective therapies to reliably improve walking. In this pilot, the investigators will test if tSCS can improve motor deficits and bladder control in children with spina bifida. The investigators are enrolling up to 20 subjects with myelomeningocele, ages 4-17 years old, that have some difficulty walking but can walk for even short distances with assistance, and that have bladder dysfunction with a stable bladder regimen. Over 4-6 weeks, children will have stimulation using non-invasive tSCS electrodes placed on their low back. Similar protocols have been used for tSCS in children with spinal cord injury and children with cerebral palsy. All previous tSCS studies have shown that this is a safe technology for use with pediatric populations. This pilot study will be used to refine the design of future randomized controlled trials to test tSCS over standard physical therapy care.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist
- •Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and/or assistance.
- •Between the ages of 4 and 17 years of age.
- •Documented neurogenic bladder dysfunction
- •On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial
排除标准
- •Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator.
- •Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months.
- •Is pregnant. Pregnancy will be assessed via verbal report.
- •Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation.
- •Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps)
- •Symptomatic urinary tract infection, urinary tract infection for which they are currently receiving treatment, scheduled urological surgery, or inability to perform or receive catheterization.
研究组 & 干预措施
Transcutaneous SCS
All participants will be receiving transcutaneous spinal cord stimulation
干预措施: Transcutaneous stimulator (Device)
研究者
Bailey Petersen
Assistant Professor
University of Pittsburgh