Cognitive Function and Glymphatic System in Children with Epilepsy

NCT ID: NCT06143241

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-29

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.

Conditions

Epilepsy; Cognitive Dysfunction; Seizure, Epileptic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

It consists of 20 children diagnosed with epilepsy who will receive inspiratory muscle training following routine medication use. The experimental group will receive inspiratory muscle training with the Thershold device for 30 minutes every day for 8 weeks.

Group Type: EXPERIMENTAL

Threshold IMT

Intervention Type: DEVICE

Threshold is used in respiratory muscle training in the form of resistance loading.

Antiepileptic medication

Intervention Type: DRUG

They will continue their antiepileptic medication prescribed by their doctor.

Control Group

The control group consists of 20 children diagnosed with epilepsy who will only be followed up with routine medication.

Group Type: ACTIVE_COMPARATOR

Antiepileptic medication

Intervention Type: DRUG

They will continue their antiepileptic medication prescribed by their doctor.

Interventions

Threshold IMT

Threshold is used in respiratory muscle training in the form of resistance loading.

Intervention Type: DEVICE

Antiepileptic medication

They will continue their antiepileptic medication prescribed by their doctor.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Miray Baser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

16.11.2023

Identifier Type: -

Identifier Source: org_study_id