An interventional study of Bobath (Neurodevelopmental Treatment) approach and Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in Children With Cerebral Palsy, sponsored by Pamukkale University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
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
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 40 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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)
Only the Bobath (Neurodevelopmental Treatment) approach will be applied.
Other: Bobath (Neurodevelopmental Treatment) approach
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).
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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pamukkale University