Combining taVNS With Early CIMT to Improve Health Outcomes of Infants With Unilateral Upper Extremity Weakness
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- CIMT Fidelity
研究概览
简要总结
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.
详细描述
Recent pioneering studies have used neuromodulation combined with intensive motor therapies in adults after stroke. Few studies have investigated combining neuromodulation and evidence-based pediatric intensive therapies such as CIMT, and then only in older children with CP to enhance neuroplasticity and improve functional outcomes. The investigators are the first to use non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) paired with a motor task of bottle-feeding in infants with feeding failure. taVNS paired with motor feeding activity was safe and over 50% infants attained full oral feeds who were slated to receive a gastrostomy tube (G-tube). With the unique collaboration of experts in brain stimulation, pediatric translational clinical science and pediatric occupational therapy in this pilot project, the investigators propose to expand the paradigm of pairing neuromodulation with motor training in at-risk infants by exploring the safety, feasibility, and effectiveness of delivering taVNS concurrently with CIMT. The hypothesis is that combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage while improving infant outcomes.
The investigators aim to determine the feasibility and safety of taVNS in at-risk infants 6-18mo undergoing CIMT therapy in open label pilot trial and assess both infant tolerability and the therapist's ability to deliver high-quality CIMT along with taVNS.
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
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have all of the following:
- •6-18 month-old infants with hemiplegia/motor asymmetry
- •Must be able to participate in high intensity CIMT
- •Gross Motor Function Classification System (GMFCS) level I-IV
排除标准
- •Must have none of the following:
- •GMFCS level V
- •severe motor impairment/quadriplegic involvement
- •uncorrected blindness or deafness
- •cardiomyopathy
研究组 & 干预措施
CIMT + taVNS
The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
CIMT + taVNS
The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia
干预措施: Constraint induced movement therapy (Other)
结局指标
主要结局
CIMT Fidelity
时间窗: at 1 month
Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
Quality of Upper Extremity Skills Test (QUEST), GRASP
时间窗: 1 month
change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment
次要结局
- Gross Motor Function Measure-88 (GMFM-88)(1 month)