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

NCT07165665 | Active Not Recruiting DMC

• 1 other identifier: E-60116787-020-729758
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Children With Cerebral Palsy

Keywords

Cerebral palsy; Children; Nervus vagus; autonomic nervous system; Quality of life; Motor function

Outcome Measures

Primary Outcomes (6)

• Demographic Data

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

  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.

• Motor Function

  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.

  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.

• Motor Function Classification

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

  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.

• Spasticity

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

  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.

• Children's Quality of Life

  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.

  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

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

  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.

Study Arms (2)

Bobath+ VNS Group

EXPERIMENTAL

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

Other: Bobath (Neurodevelopmental Treatment) approach; Device: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

Bobath Group

EXPERIMENTAL

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

Other: Bobath (Neurodevelopmental Treatment) approach

Interventions

Bobath (Neurodevelopmental Treatment) approach OTHER

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

Bobath Group; Bobath+ VNS Group

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).

Bobath+ VNS Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

VM Medical Park Bursa Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ERDOĞAN KAVLAK, PROF. DR.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc. PT. / Research Assistant

Model Details: In this study, the effects on spasticity, autonomic function, motor function, and quality of life in children with spastic cerebral palsy will be examined. The children will be divided into two groups: Bobath Group: Only the Bobath (Neurodevelopmental Treatment) approach will be applied. Bobath+ VNS Group: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied in addition to the Bobath approach. Both groups will receive treatment twice a week for 8 weeks, and spasticity, motor function, autonomic function, and quality of life will be assessed before and after the intervention.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)