Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143241
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-11-16
Brief Title:
Cognitive Function and Glymphatic System in Children with Epilepsy
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy Monitoring with Glymphatic System Activation and Neuropeptides
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Serial Digit Learning Test SDLT
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
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 Serial Digit Learning Test SDLT
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None