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Clinical Trial Summary

Epilepsy, one of the most common neurological disorders in childhood, is a chronic brain disease characterized by neurobiological, psychological and cognitive effects. Neuropeptide-Y (NPY) and neural growth factor (NGF) play a role in different pathological processes seen in epileptogenesis. Neuron-specific enolase (NSE), a quantitative indicator of brain damage, has been shown to exhibit elevated serum levels in individuals with epilepsy and is associated with cognitive functions. It is reported that the glymphatic system, which is associated with epileptic seizures, is a treatment method that can prevent cognitive impairment by preventing the accumulation of toxic waste proteins. Inspiratory muscle training, one of the respiratory physiotherapy techniques, is used as supportive treatment in patients with weak respiratory muscle strength. Weakness in respiratory muscle strength has also been detected in the epilepsy group in which the glymphatic system is affected. 40 children with epilepsy who meet the inclusion criteria and volunteer to participate in the study will participate. Children with epilepsy will be divided into two groups: experimental group (n = 20) and control group (n = 20) using the block randomization method. The experimental group will be given Inspiratory Muscle Training (IMT) with the Threshold device for 30 minutes every day for 8 weeks after routine medication use. The control group will be followed only with routine medication use. Demographic information of all participants will be recorded. Respiratory function will be evaluated with a portable spirometer device, respiratory muscle strength will be evaluated with a portable electronic mouth pressure measurement device, and cognitive performance will be evaluated with the Digit Sequence Learning Test (NSLT). Biochemical analyses; Serum levels of neuron specific enolase (NSE), neuropeptide-Y (NPY) and neural growth factor (NGF) will be determined with an ELISA kit set. The glymphatic system will be evaluated with Diffusion Tensor Imaging Analysis Across the Perivascular Space (DTI-ALPS). In both groups, the initial evaluations will be repeated after 8 weeks. This research project was planned to prevent the development of seizures and improve biochemical parameters, glymphatic system dysfunction and cognitive functions with inspiratory muscle training in pediatric epilepsy patients.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06143241
Study type Interventional
Source Ege University
Contact Miray Baser, MSc
Phone +905456936293
Email miraybaser1@gmail.com
Status Recruiting
Phase N/A
Start date March 1, 2024
Completion date August 24, 2024

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