EpilepsyNCT06143241
Cognitive Function and Glymphatic System in Children with Epilepsy
A study testing Threshold IMT and Antiepileptic medication in people with Epilepsy and Cognitive Dysfunction, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Epilepsy, Cognitive Dysfunction, Seizure, Epileptic
- What is being tested?
- Threshold IMT and Antiepileptic medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 29 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides
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.
Read more
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
- Being tested
- Threshold IMT, Antiepileptic medication
- Keywords
- Cognition, Epilepsy, Glymphatic System, Breathing Exercises
- Medical subject headings
- Epilepsy, Cognitive Dysfunction, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold IMTDevice
Threshold is used in respiratory muscle training in the form of resistance loading.
Antiepileptic medicationDrug
They will continue their antiepileptic medication prescribed by their doctor.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Device: Threshold IMT; Drug: Antiepileptic medication |
| Control Group | Active comparator | The control group consists of 20 children diagnosed with epilepsy who will only be followed up with routine medication. Receives: Drug: Antiepileptic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
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.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Spirometer
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 forced vital capacity (FVC) value will be recorded in litres and %.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Spirometer
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 the exhalation. The forced expiratory volume in one second (FEV1) value will be recorded in litres and %.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Spirometer
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 the exhalation. The forced expiratory volume in one second/forced vital capacity (FEV1/FVC) value will be recorded in litres and %.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Spirometer
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 %.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Neuron specific enolase (NSE)
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Neuropeptide-Y (NPY)
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Neural growth factor (NGF)
Blood samples will be collected interictal and serum will be separated and stored. Analyses will be performed by ELISA.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Serial Digit Learning Test (SDLT)
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.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Diffusion Tensor Imaging Analysis Across Perivascular Space (DTI-ALPS)
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.
Measured: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2024
- Primary completion24 Jun 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children diagnosed with epilepsy will be divided into two groups as experimental group and control group using block randomisation method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Baser, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143241
- Sponsor's protocol ID
- 16.11.2023
- Status last verified
- Aug 2024
- First submitted
- 16 Nov 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the research, the data of the participants and the details of the protocol applied can be requested from the responsible researcher via e-mail address in line with the necessary justifications.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Muscle Performance on Cognitive Functions in Children with Epilepsy: Monitoring with Glymphatic System Activation and Neuropeptides
- ClinicalTrials.gov ID
- NCT06143241
- Acronym / sponsor ID
- 16.11.2023
- Conditions
- Epilepsy, Cognitive Dysfunction, Seizure, Epileptic
- Keywords
- Cognition, Epilepsy, Glymphatic System, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Children diagnosed with epilepsy will be divided into two groups as experimental group and control group using block randomisation method.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Threshold IMT, Drug: Antiepileptic medicationIt 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. |
| Control Group | Active comparator | Drug: Antiepileptic medicationThe control group consists of 20 children diagnosed with epilepsy who will only be followed up with routine medication. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold IMTThreshold is used in respiratory muscle training in the form of resistance loading. | Device | Experimental Group |
| Antiepileptic medicationThey will continue their antiepileptic medication prescribed by their doctor. | Drug | Control Group, Experimental Group |
Primary outcome
Respiratory Muscle Strength
Time frame: 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.
Spirometer
Time frame: 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 forced vital capacity (FVC) value will be recorded in litres and %.
Spirometer
Time frame: 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 the exhalation. The forced expiratory volume in one second (FEV1) value will be recorded in litres and %.
Spirometer
Time frame: 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 the exhalation. The forced expiratory volume in one second/forced vital capacity (FEV1/FVC) value will be recorded in litres and %.
Spirometer
Time frame: 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 %.
Neuron specific enolase (NSE)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Serial Digit Learning Test (SDLT)
Time frame: 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.
Diffusion Tensor Imaging Analysis Across Perivascular Space (DTI-ALPS)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. At the end of the research, the data of the participants and the details of the protocol applied can be requested from the responsible researcher via e-mail address in line with the necessary justifications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold IMT and Antiepileptic medication in people with Epilepsy and Cognitive Dysfunction, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: It will be measured at baseline and at the end of the experiment (at the end of 8 weeks).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.