Optimization of Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hand grip
研究概览
简要总结
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.
详细描述
After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, the investigators will recruit and enroll 10 participants. In the first week, participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function. On day 5, eligible participants will have experimental assessments to measure hand grip and control, both with and without spinal cord stimulation (scTS) at one or two neck sites optimized to improve hand grip. On day 6, participants will have similar assessments, this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control.
For the third aim, 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come, first-served basis. They will undergo 20 sessions of activity-based upper extremity training, followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2. After completing the training, participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For aim 1 and 2, 10 participants with SCI:
- •age 7-12 years;
- •chronic (>6 months), acquired upper motor neuron SCI;
- •cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
- •Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
- •For Aim 3, 4 participants with SCI who:
- •complete aim 1 and 2;
- •consent/assent for aim 3
- •demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
- •confirmed volitional activation in hand muscles during hang grip assessment without scTS
排除标准
- •For all 3 aims will include:
- •Botox use within past 3 months (for upper or lower extremity);
- •current oral baclofen (or pump);
- •musculoskeletal impairment limiting range of motion;
- •unhealed fracture or other medical condition limiting participation in AB-UET;
- •etiology of spina bifida;
- •total ventilator dependence.
研究组 & 干预措施
Activity based upper extremity training
Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session.
干预措施: Activity based upper extremity training with and without stimulation (Device)
Activity based upper extremity training with stimulation
Activity-based upper extremity training (AB-UET + scTS) will be administered 5d/week and 1 hour 30 minutes/session. UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of ~ 10 minute/bouts.
干预措施: Activity based upper extremity training with and without stimulation (Device)
结局指标
主要结局
Hand grip
时间窗: 12 weeks
Voluntary maximal hand grip force
Hand control
时间窗: 12 weeks
Peak to peak distance on hand grip force
次要结局
- Functional neurophysiological assessment-Upper extremity(12 weeks)
- Pediatric Neurorecovery scale(12 weeks)
- Box and block test(12 weeks)
- Capabilities of upper extremity test(12 weeks)
研究者
Goutam Singh
Assistant Professor
University of Louisville