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NCT06143241 | COMPLETED | Epilepsy


Cognitive Function and Glymphatic System in Children with Epilepsy
Sponsor:

Ege University

Information provided by (Responsible Party):

Behavior

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.

Condition or disease

Epilepsy

Cognitive Dysfunction

Seizure, Epileptic

Intervention/treatment

Threshold IMT

Antiepileptic medication

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : DOUBLE
Masking Description : Patients will not be informed about the intergroup practice. The person who will carry out the evaluations will not be informed about the application.
Primary Purpose : TREATMENT
Official Title : The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2024-06-24
Estimated Study Completion Date : 2024-09-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Cognitive Function and Glymphatic System in Children with Epilepsy

Location Details

NCT06143241


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Locations


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Turkey, Bornova

Ege University

Izmir, Bornova, Turkey, 35080

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