Status:
ACTIVE_NOT_RECRUITING
The Effect of Nervus Vagus Stimulation on Spasticity, Autonomic Function, Motor Function and Quality of Life in Children With Spastic Cerebral Palsy
Lead Sponsor:
Pamukkale University
Conditions:
Children With Cerebral Palsy
Eligibility:
All Genders
8-18 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Participants will be withdrawn from the study if they are unable to complete the administered tests, assessments, or questionnaires.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.
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07165665
Start Date
September 29 2025
End Date
September 30 2026
Last Update
November 18 2025
Active Locations (1)
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1
VM Medical Park Bursa Hospital
Bursa, Turkey (Türkiye)