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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The control group will receive only the standard Bobath (Neurodevelopmental Treatment, NDT) approach.
The intervention group will receive the standard Bobath (Neurodevelopmental Treatment, NDT) approach combined with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS).
VM Medical Park Bursa Hospital
Bursa, Turkey (Türkiye)
Demographic Data
Demographic Data Form: Sociodemographic data form will be created for the patients.
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.
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.
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.
Motor Function Classification
GMFCS: Classifies the motor function levels of children with CP into 5 levels.
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.
Spasticity
MAS: Assesses the degree of spasticity on a scale from 0 to 4.
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.
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.
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
Autonomic Function: Parasympathetic and sympathetic activities will be measured using HRV analyses
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.
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