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NCT06143241Completed

Cognitive Function and Glymphatic System in Children with Epilepsy

The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides

Source: ClinicalTrials.gov · Last updated 15 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
16 Nov 2023
Start date
1 Mar 2024
Primary completion date
24 Jun 2024
Lead sponsor
Ege University
Diseases
Epilepsy
NCT number
NCT06143241

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 1 Mar 2024 to the primary completion date, 24 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving ketogenic diet application.
  • The presence of orthopedic surgery.

Other illness

  • Diagnosed with respiratory system disease.
  • 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.

Other

  • Has kyphoscoliosis and/or advanced postural alignment problems that affect respiratory function.
  • Have severe mental problems.

Who the study is looking for

  • 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.

Age in the registry: 8 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ege University
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.