Status:
ACTIVE_NOT_RECRUITING
Nervus Vagus Stimulation and Cerebral Palsy
Lead Sponsor:
Istanbul Medipol University Hospital
Conditions:
Cerebral Palsy, Spastic
Eligibility:
All Genders
2-15 years
Phase:
PHASE1
Brief Summary
When the literature is reviewed, it is difficult to find direct research on the effects of auricular vagus nerve stimulation (aVNS) on the autonomic nervous system and spasticity in children with spas...
Detailed Description
Individuals aged 2-15 years who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and were diagnosed with cerebral palsy (CP) by a physical medicine and ...
Eligibility Criteria
Inclusion
- Diagnosis of spastic CP,
- Individuals aged 2-15 years,
- Written informed consent from parents or legal guardians and the willingness of the children to participate in the study,
- Clinically stable children without acute illnesses or comorbidities that could affect autonomic function or spasticity during the study period.
Exclusion
- Children with severe intellectual disabilities who cannot understand or respond to the study procedures,
- Children with uncontrolled cardiovascular, respiratory, or autonomic disorders (e.g., arrhythmia, severe asthma),
- Children with devices such as pacemakers or cochlear implants that could be affected by vagus nerve stimulation,
- Children for whom vagus nerve stimulation may interact with antiepileptic drugs or affect seizures,
- Children or parents who cannot comply with the study protocol or cooperate.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06880887
Start Date
March 1 2025
End Date
May 1 2025
Last Update
March 18 2025
Active Locations (1)
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1
Mudanya University
Bursa, Bursa, Turkey (Türkiye), 16160