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

NCT ID: NCT07165665

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bobath+ VNS Group

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

Group Type: EXPERIMENTAL

Bobath (Neurodevelopmental Treatment) approach

Intervention Type: OTHER

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

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

Intervention Type: DEVICE

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

Bobath Group

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

Group Type: EXPERIMENTAL

Bobath (Neurodevelopmental Treatment) approach

Intervention Type: OTHER

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

Interventions

Bobath (Neurodevelopmental Treatment) approach

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

Intervention Type: OTHER

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Server ERDOĞMUŞ

Msc. PT. / Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ERDOĞAN KAVLAK, PROF. DR.

Role: STUDY_DIRECTOR

Locations

VM Medical Park Bursa Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-60116787-020-729758

Identifier Type: -

Identifier Source: org_study_id