Harnessing Early Neuroplasticity in Infants With Perinatal Brain Injury: A Study of Combined Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) Paired With Constraint Induced Movement Therapy (CIMT) and Transcranial Magnetic Stimulation (TMS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
研究概览
简要总结
This study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury. This is a time when investigators think they can best help improve how the brain controls movement. Investigators are testing whether the combination of transcutaneous auricular vagus nerve stimulation (taVNS) with 40 hours of constraint-induced movement therapy (CIMT) can help infants move their weaker arm and hand better and make the brain pathways for movement stronger.
详细描述
Primary Objective • To evaluate the feasibility of using spTMS to elicit motor-evoked potentials (MEPs) in infants with hemiplegic cerebral palsy (CP) due to perinatal brain injury and to determine whether baseline MEP characteristics predict motor response to a 40-hour intervention combining taVNS with CIMT.
Exploratory Objective:
• To investigate neuroplastic changes in cortical motor circuitry associated with taVNS-paired CIMT by examining longitudinal changes in MEP topography and corresponding motor function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 8 to 24 months, diagnosed with hemiplegia or with an evident unilateral upper-limb weakness due to perinatal brain injury
- •Gross Motor Function Classification System (GMFCS) level I-IV
- •Infants who have not received previous CIMT in the preceding 3 months
- •Able to make consecutive appointments for assessments and intervention over 2 weeks, and complete the 3-month follow-up.
排除标准
- •GMFCS level V
- •Prior CIMT within the past 3 months
- •Severe motor impairment/quadriplegic involvement.
- •Uncontrolled seizure disorders, cardiomyopathy, severe congenital malformations,
- •significant sensory impairments, or conditions preventing safe participation in therapy sessions
研究组 & 干预措施
Infants and Toddlers with Perinatal Brain Injury
Therapy sessions in this study will take 4 hours a day, 5 days a week for 2 weeks (40 hours total CIMT). Sticker like sensors (electrodes) are placed just inside and outside the child's left earlobe at the start of the session to deliver the taVNS. During daily therapy sessions, the taVNS will be on whenever the child moves their free arm, for up to 2.5 minutes at a time.
干预措施: Transcutaneous auricular vagus nerve stimulation (taVNS) (Device)
Infants and Toddlers with Perinatal Brain Injury
Therapy sessions in this study will take 4 hours a day, 5 days a week for 2 weeks (40 hours total CIMT). Sticker like sensors (electrodes) are placed just inside and outside the child's left earlobe at the start of the session to deliver the taVNS. During daily therapy sessions, the taVNS will be on whenever the child moves their free arm, for up to 2.5 minutes at a time.
干预措施: Constraint-Induced Movement Therapy (CIMT) (Behavioral)
结局指标
主要结局
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
时间窗: baseline (Day 1)
Motor-evoked potentials (MEPs) are electrical responses recorded from a muscle following a brief magnetic pulse delivered to the brain using single-pulse transcranial magnetic stimulation (spTMS). This outcome measures the proportion of participants in whom a reliable MEP can be elicited at baseline and serves as a measure of the feasibility of assessing corticospinal connectivity in infants with perinatal brain injury.
Completion rate of spTMS sessions
时间窗: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
This outcome measures the proportion of planned spTMS assessment sessions that are successfully completed at baseline, post-intervention, and 3-month follow-up. Completion rates will be used to evaluate the feasibility, tolerability, and practicality of conducting repeated spTMS assessments in infants and toddlers with perinatal brain injury.
次要结局
- Baseline MEP Amplitude(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)
- Percent change in Mini-Assisting Hand Assessment (mini-AHA) score from baseline to end of treatment(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)
- Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)
- Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)
- Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)
- Gross Motor Function Measure (GMFM-88)(baseline (Day 1), post-intervention (Day 12), 3 month follow-up)