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NCT Number: NCT07165665

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Children with Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VM Medical Park Bursa Hospital

Bursa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Bobath (Neurodevelopmental Treatment) approach

Other

The control group will receive only the standard Bobath (Neurodevelopmental Treatment, NDT) approach.

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

Device

The intervention group will receive the standard Bobath (Neurodevelopmental Treatment, NDT) approach combined with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS).

Primary outcomes

  1. Demographic Data

    Time frame: 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.

  2. Motor Function

    Time frame: 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.

  3. Motor Function Classification

    Time frame: 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.

  4. Spasticity

    Time frame: 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.

  5. Children's Quality of Life

    Time frame: 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.

  6. Autonomic Function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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