NCT06143241

Cognitive Function and Glymphatic System in Children with Epilepsy

Completed NA Last updated 15 October 2024

What this trial tests

NA trial testing Threshold IMT in Epilepsy in 20 participants. Completed in 29 September 2024.

Timeline

1 March 2024

Primary endpoint
24 June 2024

29 September 2024

Quick facts

Lead sponsor	Ege University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 March 2024
Primary completion	24 June 2024
Estimated completion	29 September 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Threshold IMT
• Antiepileptic medication — full drug profile →

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
• Seizure, Epileptic — all drugs for Seizure, Epileptic →

Sponsor

Ege University

Who can join

Adults 8 to 17, any sex, with Epilepsy or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current understanding and prospects for targeting neurogenesis in the treatment of cognitive impairment.
   Liu Y, Ding X, Jia S, Gu X. · · 2026 · cited 10× · PMID 39820472 · DOI 10.4103/nrr.nrr-d-24-00802