The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Spirometer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will not be informed about the intergroup practice. The person who will carry out the evaluations will not be informed about the application.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Threshold IMT (Device)
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.
干预措施: Antiepileptic medication (Drug)
Control Group
The control group consists of 20 children diagnosed with epilepsy who will only be followed up with routine medication.
干预措施: Antiepileptic medication (Drug)
结局指标
主要结局
Spirometer
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
It will be performed using a portable spirometer (Cosmed Pony FX, Italy). The test will be performed in a seated position with the patient being asked to first take a deep breath and then exhale rapidly into the spirometer device. A nose clip will be used during exhalation. The peak expiratory flow (PEF) value will be recorded in litres and %.
Serial Digit Learning Test (SDLT)
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Evaluates short-term memory and learning ability. In the test content, there are two separate sequences of 8 or 9 digits in which the digits from 1 to 9 are mixed according to the age and education level of the participant. The selected sequence is read to the subject in order and the subject is asked to remember and say the sequence in the correct order.
Neuron specific enolase (NSE)
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Neuropeptide-Y (NPY)
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Neural growth factor (NGF)
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Diffusion Tensor Imaging Analysis Across Perivascular Space (DTI-ALPS)
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
It is used to measure glymphatic system activation. A rectangular ROI is drawn and fiber orientations and diffusivities in all three directions along the x-, y-, and z-axes are obtained as voxel levels. Among several voxels, for each fiber on the same x-axis (projection, association, and subcortical fibers), one voxel is selected that shows the most common orientation in each fiber. The DTI-ALPS index is the average of two sets of diffusivity values perpendicular to the dominant fibers in the tissue, namely the x-axis diffusivity in the area of projection fibers (Dxproj) and the x-axis diffusivity in the area of association fibers (Dxassoc), the y-axis diffusivity in the area of projection fibers (Dyproj) and the area of association fibers. It is calculated as the ratio of the z-axis diffusivity (Dzaccoc) to its average.
Respiratory Muscle Strength
时间窗: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Respiratory muscle strength will be measured according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria using a portable electronic mouth pressure measurement device (micro RPM). A measurement result of 80 cmH2O and above indicates a good result.
次要结局
未报告次要终点
研究者
Miray Baser
Principal Investigator
Ege University