Clinical trial NCT06143241: Cognitive Function and Glymphatic System in Children with Epilepsy
Official title: The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Cognitive Dysfunction
Seizure, Epileptic
Keywords: Cognition
Epilepsy
Glymphatic System
Breathing Exercises
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children diagnosed with epilepsy will be divided into two groups as experimental group and control group using block randomisation method.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with absence and rolandic type epilepsy according to the International League Against Epilepsy (ILAE) classification.
* No previous respiratory physiotherapy.
* Maximal Inspiratory Pressure (MIP) value is below the expected value according to age and gender.
* Co-operative.

Exclusion Criteria:

* Diagnosed with respiratory system disease.
* Has kyphoscoliosis and/or advanced postural alignment problems that affect respiratory function.
* Have severe mental problems.
* Receiving ketogenic diet application.
* Have any neuromuscular disease.
* Have severe cardiac involvement, pulmonary embolism, mesenteric or portal thrombosis.
* Diagnosis of inflammatory disease or C-reactive protein (CRP) analysis above normal limits.
* The presence of orthopedic surgery.

Primary outcomes:
measure: Respiratory Muscle Strength
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Spirometer
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Spirometer
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Spirometer
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Spirometer
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Neuron specific enolase (NSE)
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Neuropeptide-Y (NPY)
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Neural growth factor (NGF)
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Serial Digit Learning Test (SDLT)
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
measure: Diffusion Tensor Imaging Analysis Across Perivascular Space (DTI-ALPS)
timeFrame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References: