The Acute Effects of Vagus Nerve Stimulation on the Autonomic Nervous System and Spasticity in Children with Spastic Cerebral Palsy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Muscle Spastisity Value
研究概览
简要总结
When the literature is reviewed, it is difficult to find direct research on the effects of auricular vagus nerve stimulation (aVNS) on the autonomic nervous system and spasticity in children with spastic cerebral palsy. However, there is a substantial body of literature on the potential of vagus nerve stimulation (VNS) to modulate autonomic functions.
The aim of this study is to investigate the potential effects of vagus nerve stimulation, which is known to influence the autonomic nervous system, in individuals with spastic cerebral palsy and to explore its contributions to spasticity.
详细描述
Individuals aged 2-15 years who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and were diagnosed with cerebral palsy (CP) by a physical medicine and rehabilitation physician or neurologist will be included in the study. A total of 20 participants were included in the study, and the necessary measurements were taken before and after the intervention.
The demographic characteristics of participants who meet the inclusion criteria will be recorded. After collecting sociodemographic characteristics, the following assessment methods will be applied, and the results will be recorded in the pre- and post-intervention evaluation form.
Evaluation After collecting the sociodemographic information of the included individuals, their Gross Motor Function Classification System (GMFCS) levels will be assessed and recorded. GMFCS is a scale that evaluates and classifies the gross motor skills of children with CP. It determines the walking abilities and levels of independence in physical activities of the children.
The 5 levels of GMFCS are defined as follows:
Level I (High Functional Level): Children at this level can walk and show limited success in complex movements such as running. They can usually climb stairs and use motor skills independently.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spastic CP,
- •Individuals aged 2-15 years,
- •Written informed consent from parents or legal guardians and the willingness of the children to participate in the study,
- •Clinically stable children without acute illnesses or comorbidities that could affect autonomic function or spasticity during the study period.
排除标准
- •Children with severe intellectual disabilities who cannot understand or respond to the study procedures,
- •Children with uncontrolled cardiovascular, respiratory, or autonomic disorders (e.g., arrhythmia, severe asthma),
- •Children with devices such as pacemakers or cochlear implants that could be affected by vagus nerve stimulation,
- •Children for whom vagus nerve stimulation may interact with antiepileptic drugs or affect seizures,
- •Children or parents who cannot comply with the study protocol or cooperate.
结局指标
主要结局
Muscle Spastisity Value
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
The Modified Ashworth Scale (MAS) is a widely used tool to assess spasticity, measuring muscle tone in conditions like cerebral palsy, stroke, and spinal cord injuries. Spasticity causes abnormal muscle contractions and movement limitations. MAS evaluates muscle resistance during joint movements, grading spasticity from 0 (no spasticity) to 4 (joint movement impossible due to high muscle tone). It provides a simple, quick, and reliable method for monitoring spasticity, aiding in treatment planning and rehabilitation. Studies, such as Bohannon and Smith (1987), confirm its reliability in clinical practice, making it valuable for assessing treatment response and intervention needs.
Autonomic Nervous System Activity Value/RMSSD
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device. Key parameters include: RMSSD: Reflects parasympathetic activity and forms the basis of HRV and and is expressed in milliseconds
Autonomic nervous system activity - LF/HF
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.LF/HF Ratio: Measures sympathovagal balance.
Autonomic nervous system activity/ LF Power
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.LF Power: Indicates sympathetic activity (0.04-0.15 Hz range) and t is expressed as the square of milliseconds
Autonomic nervous system activity / HF Power
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
The autonomic nervous system cannot be directly evaluated through physiological tests. However, advancements in technology have introduced methods like heart rate variability (HRV) analysis, widely used in scientific research. HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.HF Power: Represents parasympathetic activity (0.15-0.40 Hz range) and t is expressed as the square of milliseconds
Heart Rate
时间窗: The assessments will be conducted before and immediately after the application of vagus nerve stimulation (VNS).
HRV analysis measures RR waves during rest and will be employed in this study using the Elite HRV Corsense device.The participants' average heart rate will be recorded in beats per minute (bpm).
次要结局
- Regression Analysis of Gross Motor Function Classification System (GMFCS) Levels(Regression analysis will use post-stimulation data, comparing baseline GMFCS, spasticity, and autonomic activity to assess GMFCS's predictive role in vagus nerve stimulation effectiveness.)
研究者
gulay karacaoglu
Assitant prof.
Istanbul Medipol University Hospital