Children With Cerebral PalsyNCT07165665
The Effect of Nervus Vagus Stimulation on Spasticity, Autonomic Function, Motor Function and Quality of Life in Children With Spastic Cerebral Palsy
A study testing Bobath (Neurodevelopmental Treatment) approach and Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in people with Children With Cerebral Palsy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Children With Cerebral Palsy
- What is being tested?
- Bobath (Neurodevelopmental Treatment) approach and Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to 14 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Bobath (Neurodevelopmental Treatment) approach, Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)
- Keywords
- Cerebral palsy, Children, Nervus vagus, autonomic nervous system, Quality of life, Motor function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath (Neurodevelopmental Treatment) approachOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Bobath+ VNS Group | Experimental | Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied in addition to the Bobath approach. Receives: 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. Receives: Other: Bobath (Neurodevelopmental Treatment) approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Data
Demographic Data Form: Sociodemographic data form will be created for the patients.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start29 Sep 2025
- Primary completion10 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Server ERDOĞMUŞ, Pamukkale University
- Investigators
- ERDOĞAN KAVLAK, PROF. DR., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165665
- Sponsor's protocol ID
- E-60116787-020-729758
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nervus Vagus Stimulation on Spasticity, Autonomic Function, Motor Function and Quality of Life in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07165665
- Acronym / sponsor ID
- E-60116787-020-729758
- Conditions
- Children With Cerebral Palsy
- Keywords
- Cerebral palsy, Children, Nervus vagus, autonomic nervous system, Quality of life, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bobath+ VNS Group | Experimental | Other: Bobath (Neurodevelopmental Treatment) approach, Device: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied in addition to the Bobath approach. |
| Bobath Group | Experimental | Other: Bobath (Neurodevelopmental Treatment) approachOnly the Bobath (Neurodevelopmental Treatment) approach will be applied. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bobath (Neurodevelopmental Treatment) approachThe control group will receive only the standard Bobath (Neurodevelopmental Treatment, NDT) approach. | Other | Bobath Group, Bobath+ VNS Group |
| 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). | Device | Bobath+ VNS Group |
Primary outcome
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.
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERDOĞAN KAVLAK, PROF. DR. study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath (Neurodevelopmental Treatment) approach and Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in people with Children With Cerebral Palsy, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.