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Neuro-MoD: Neuroplasticity With Motor Development

2026年9月11日 更新者：University of Wisconsin, Madison

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)

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Bernadette Gillick, PhD, MSPT
  • 电话号码：608-262-7457
  • 邮箱：bgillick@wisc.edu

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：Constraint-Induced Movement Therapy (CIMT)
CIMT involves placing a mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions.
设备：Transcutaneous auricular vagus nerve stimulation (taVNS)
Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
大体时间：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.
baseline (Day 1)
Completion rate of spTMS sessions
大体时间：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.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up

次要结果测量

结果测量
措施说明
大体时间
Baseline MEP Amplitude
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
MEP amplitude will be reported in millivolts (mV), measured from electromyography recordings of the target muscle.
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
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
The mini-AHA evaluates how effectively infants with unilateral upper extremity impairment use their affected hand during bimanual play activities. Scores are reported on a standardized 0-100 scale, with higher scores indicating greater functional use of the affected hand and lower scores indicating less functional use.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up

This is a measure of movement, scored in several domains: dissociated movement (joint mobility), grasp (holding and manipulating objects), protective extension (reflex reactions), and weight bearing assessments. It is scored from 0 to 100 where higher scores mean better movement.

Change in QUEST score from baseline will be used to assess changes in upper extremity function following the intervention.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Fine Motor subtest evaluates fine motor skills, including reaching, grasping, object manipulation, and hand-eye coordination. Scores are standardized based on age and range from 1 to 19, with a normative mean of 10 and standard deviation of 3. Scores in the range of 8-12 are generally considered within the typical range for age. Higher scores indicate more advanced motor development.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Gross Motor subtest evaluates gross motor skills, including posture, sitting, crawling, standing, walking, and other age-appropriate movement abilities. Scores are standardized based on age and range from 1 to 19, with a normative mean of 10 and standard deviation of 3. Scores in the range of 8-12 are generally considered within the typical range for age. Higher scores indicate more advanced motor development.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Gross Motor Function Measure (GMFM-88)
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
The Gross Motor Function Measure-88 (GMFM-88) evaluates gross motor function across five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Items are scored on a 4-point scale and converted to dimension and total scores ranging from 0 to 100. Higher scores indicate better gross motor function and greater ability to perform age-appropriate motor activities.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up

其他结果措施

结果测量
措施说明
大体时间
MEP Amplitude
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Motor-evoked potential (MEP) amplitude measures the strength of the muscle response produced after a brief magnetic pulse is applied to the brain using single-pulse transcranial magnetic stimulation (spTMS). Larger amplitudes indicate stronger communication between the brain and the target muscle. MEP amplitude will be reported in millivolts (mV).
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
MEP Threshold
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Motor-evoked potential (MEP) threshold is the minimum level of magnetic stimulation needed to produce a muscle response. Lower thresholds generally indicate that the pathway between the brain and muscle can be activated more easily. MEP threshold will be reported as a percentage of maximum stimulator output (%MSO).
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Cortical Map Topography
大体时间：baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Cortical map topography describes the location and distribution of brain areas that produce muscle responses when stimulated using single-pulse transcranial magnetic stimulation (spTMS). Changes in the size, location, or organization of these areas over time may reflect changes in brain connectivity and neuroplasticity.
baseline (Day 1), post-intervention (Day 12), 3 month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Wisconsin, Madison

调查人员

  • 首席研究员：Bernadette Gillick, PhD, MSPT、UW School of Medicine and Public Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-0790
  • ICTR Pilot Award (其他赠款/资助编号：NCATS)
  • Protocol Version 6/17/26 (其他标识符：UW Madison)
  • SMPH/Pediatrics/Dev & Reh Med (其他标识符：UW Madison)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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