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临床试验/NCT07165665
NCT07165665已完成不适用

The Effect of Nervus Vagus Stimulation on Spasticity, Autonomic Function, Motor Function and Quality of Life in Children With Spastic Cerebral Palsy

Pamukkale University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Demographic Data

研究概览

简要总结

Introduction:

Cerebral palsy (CP) is a heterogeneous neurodevelopmental syndrome affecting muscle tone, motor skills, and movement due to brain injury during developmental stages. The etiology of CP is associated with factors such as prematurity, low birth weight, and pregnancy or birth complications. The spastic type is the most common motor disorder, characterized by increased reflexes and muscle hypertonia in the extremities. Spasticity arises from upper motor neuron lesions, leading to dysregulation in spinal and brain pathways (corticospinal, reticulospinal, vestibulospinal) and involves complex modulation of muscle tone and stretch reflexes.

The autonomic nervous system regulates visceral functions, while the vagus nerve, through its parasympathetic fibers, exerts widespread influence on the heart, respiratory system, and gastrointestinal system. It controls organ function via motor, sensory, and parasympathetic fibers originating from three medullary nuclei (nucleus ambiguus, dorsal motor nucleus, and nucleus solitarius). Vagus nerve stimulation (VNS) modulates the central nervous system by stimulating afferent fibers, increasing GABA and other inhibitory neurotransmitter levels, reducing excitatory signals, and potentially influencing spasticity. VNS can be applied invasively or non-invasively (transcutaneous VNS, tVNS); particularly, tVNS applied to the left ear is a safe and well-tolerated method with therapeutic potential in epilepsy and motor disorders.

This study aims to investigate the effects of non-invasive auricular vagus nerve stimulation (taVNS) combined with the Bobath approach on motor function, autonomic function, spasticity, activities of daily living, and quality of life in children with spastic cerebral palsy (CP).

Materials and Methods:

Planned as a prospective, controlled study, children with CP will be randomly assigned to two groups. The intervention group will receive the standard Bobath program administered by physiotherapists with at least 3 years of experience, combined with transcutaneous auricular vagus nerve stimulation (taVNS). The control group will receive only the Bobath approach. Both groups will undergo therapy twice a week for 8 weeks.

Outcome Measures:

Motor function: Assessed using the Gross Motor Function Measure (GMFM-88) and the Gross Motor Function Classification System (GMFCS).

Spasticity: Measured with the Modified Ashworth Scale (MAS).

Quality of life: Evaluated using the Pediatric Quality of Life Inventory (PedsQL).

Autonomic function: Heart rate variability (HRV) analyzed using the Elite HRV Corsense device. Measured parameters include RMSSD, LF power, HF power, LF/HF ratio, and mean heart rate.

Inclusion Criteria:

Diagnosis of spastic cerebral palsy

Aged 8-18 years

MAS score between 1 and 3

GMFCS Level I-III

Adequate cognitive level

No previous vagus nerve stimulation

No cardiovascular or chronic respiratory disease

Informed consent from parent/legal guardian

Exclusion Criteria:

Severe cardiovascular or pulmonary disease

Respiratory failure requiring mechanical ventilation

History of epilepsy or active seizures

MAS 0 or 4, GMFCS IV-V

Skin conditions in the neck/ear region preventing stimulation

Inability to obtain sufficient consent or perform assessments

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with spastic cerebral palsy
  • Aged between 8 and 18 years
  • No chronic respiratory or cardiovascular disease
  • Having spasticity between 1 and 3 according to the Modified Ashworth Scale (MAS)
  • Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
  • Sufficient cognitive ability to participate in the study and complete assessments
  • No previous vagus nerve stimulation and no contraindications for the procedure
  • No congenital or acquired cardiovascular disease
  • Written informed consent obtained from parents or legal guardians

排除标准

  • History of congenital or acquired severe cardiovascular or pulmonary disease
  • Requirement of mechanical ventilation due to respiratory failure
  • History of epilepsy or active seizures
  • Previous vagus nerve stimulation
  • Inability to complete assessments due to severe cognitive impairment
  • Having spasticity of 0 or 4 according to the Modified Ashworth Scale (MAS)
  • Classified as Level IV-V according to the Gross Motor Function Classification System (GMFCS)
  • Presence of skin disease in the neck or ear region or any condition preventing vagus nerve stimulation
  • Inability to obtain parental/legal guardian consent for participation in the study
  • Withdrawal Criteria for Participants:
  • Participants will be withdrawn from the study if they are unable to complete the administered tests, assessments, or questionnaires.
  • Study Termination Criteria:
  • The study will be concluded once the planned sample size has been reached.

研究组 & 干预措施

Bobath+ VNS Group

Experimental

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied in addition to the Bobath approach.

干预措施: Bobath (Neurodevelopmental Treatment) approach (Other)

Bobath+ VNS Group

Experimental

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied in addition to the Bobath approach.

干预措施: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) (Device)

Bobath Group

Experimental

Only the Bobath (Neurodevelopmental Treatment) approach will be applied.

干预措施: Bobath (Neurodevelopmental Treatment) approach (Other)

结局指标

主要结局

Demographic Data

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

Demographic Data Form: Sociodemographic data form will be created for the patients.

Motor Function

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

GMFM-88: A scale consisting of 88 items across 5 subscales, used to assess gross motor functions in children. Scoring is done using a 0-3 Likert scale, and the average of the percentage scores for each subscale is calculated to obtain the total score.

Motor Function Classification

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

GMFCS: Classifies the motor function levels of children with CP into 5 levels.

Spasticity

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

MAS: Assesses the degree of spasticity on a scale from 0 to 4.

Children's Quality of Life

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

PedsQL (Children's Quality of Life Scale): Measures quality of life in children aged 2-18, covering physical, emotional, social, and school functioning. Scores are linearly converted to a 0-100 scale.

Autonomic Function

时间窗: A pre-test will be conducted to determine participants' baseline levels before the intervention; assessments will be repeated at 8 weeks (post-intervention) to evaluate changes.

Autonomic Function: Parasympathetic and sympathetic activities will be measured using HRV analyses

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Server ERDOĞMUŞ

Msc. PT. / Research Assistant

Pamukkale University

研究点 (1)

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