Epilepsy; Syndrome, Seizures of Localized OnsetlevcbzNCT06138847
Does Levetiracetam and Carbamazepine Impact the Autonomic Activity of Children With Self-limiting Focal Epilepsy?
An observational study of Epilepsy; Syndrome, Seizures of Localized Onset, run by İpek Dokurel at 1 site in Turkey (Türkiye).
Trial summary
The goal of this cross-sectional study is to learn about autonomic cardiac profile changes in children with self-limiting focal epilepsy using levetiracetam and carbamazepine in children with self-limiting focal epilepsy syndrome. The main questions is it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Epilepsy; Syndrome, Seizures of Localized Onset
- What is being tested?
- electroencephalogram
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 2 Dec 2023
- Phase
- Observational
- 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 5 to 17 years
- All sexes
- Child
Study population: Seventy-eight children aged 5-17 years old with with self-limiting focal epilepsy syndrome were enrolled in the study and were divided into two groups. Group I consisted of children with epilepsy who were only taking one type of ASMs, either levetiracetam or carbamazepine. They were further subdivided into group Ia, which included patients receiving levetiracetam and group Ib, which included patients receiving carbamazepine. Group II comprised forty-one age and sex-matched healthy children as a control group.
Who may be able to join
- Based on the ILAE classification, all children with epilepsy are categorized as self-limiting focal epilepsy syndromes.
Who cannot join
- had signs of organic heart disease
- had other conditions that could influence the cardiovascular and autonomic nervous systems (such as systemic lupus erythematosus, and endocrine-metabolic abnormalities)
- use regular medications that have an impact on the cardiovascular and autonomic nervous systems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balıkesir University Medical Faculty
Center, Balikesi̇r, 10100
About this study
The goal of this cross-sectional study is to learn about autonomic cardiac profile changes in children with self-limiting focal epilepsy using levetiracetam and carbamazepine in children with self-limiting focal epilepsy syndrome. The main questions is it aims to answer are:
- Are heart rate variability and autonomic tone different among healthy controls and children with epilepsy?
- Does Levetiracetam and carbamazepine affect autonomic tone differently among children with self-limiting focal epilepsy?
Read the detailed description
Seventy-eight children with self-limiting focal epilepsy syndrome were enrolled in the study and were divided into two groups. Group I consisted of children with epilepsy who were only taking one type of ASM, either levetiracetam or carbamazepine. They were further subdivided into group Ia, which included patients receiving levetiracetam, and group Ib, which included patients receiving carbamazepine. Group II comprised forty-one age and sex-matched healthy children as a control group.
The pediatric neurologist utilized the clinical definition criteria of the International League Against Epilepsy to diagnose all children with self-limiting focal epilepsy syndrome.
The demographics, clinical data, neuroimaging findings, interictal scalp EEG results, and outcomes of patients' medical records were examined retrospectively. Utilizing the 10-20 system, gold cup electrodes (accompanied by conductive paste and collodium) were placed and used to acquire scalp recordings. Polygraphic derivations generally include an ECG channel, standard EEG recordings, plus an optional EMG channel.
All subjects had echocardiographic (ECHO) testing using M-mode, 2-dimensional, color, pulse, and continuous wave Doppler echocardiograms with a GE Vivid S6. A standard ambulatory electrocardiography (ECG) recording system (Cardioline Click Holter HRV Package System, version 1.4.1 Biomedical Systems, Italy) was used. All of the patients were examined during an at least 24- hour seizure-free period, and none of the patients reported seizures during the recording period and encouraged to perform their normal daily activities. Artifacts and ectopic complexes were excluded. Heart rate variability parameters used for the time domain analysis were the mean and the highest and lowest heart rates. Time domain analysis included the following: standard deviation (SD) of all normal RR intervals (SDNN, ms), SD of the average normal sinus intervals between successive heartbeats (RR intervals) for all 5 min segments of the entire recording (SDANN, ms), the root mean squares successive differences RR intervals (RMSSD, ms), the proportion of the adjacent RR intervals that differ by more than 50 ms in the 24- hour recording (pNN50, measured in percentage). While the RMSSD and pNN50 reflect vagally mediated (i.e., parasympathetic) HRV, the SDNN represents the parasympathetic and sympathetic components of the autonomic nervous system.
The rSUDEP-7 inventory was used to assess group I risk for SUDEP. The SUDEP-7 was found to be associated with a biomarker of vagus-mediated HRV(RMSSD)[25]. The revised SUDEP-7 Risk Inventory incorporates seven validated risk factors (Table 1). Since our study cohort consisted of the pediatric age group and the study design was based on patients receiving monotherapy, none of group 1 received points from the 5th and 6th items of the risk factor list.
- Being tested
- electroencephalogram
- Keywords
- Heart rate variability, epilepsy, children, carbamazepine, levetiracetam, rSUDEP-7
- Medical subject headings
- Epilepsy, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalogramDiagnostic test
Polygraphic derivations generally include an ECG channel, which is standard on EEG recordings, plus an optional EMG channel. Subsequently, the signal was recorded at 512 Hz and inspected using the standard bipolar and referential montages
| Study group | Role | What they receive |
|---|---|---|
| Group I | Group I consisted of children with epilepsy who were only taking one type of ASMs, either levetiracetam or carbamazepine Receives: Diagnostic Test: electroencephalogram | |
| Group II | Group II comprised forty-one age and sex-matched healthy children as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
children with epilepsy has autonomic disfunction
children with self-limiting focal epilepsy syndrome on monotherapy evinced parasympathetic cardiac autonomic dysfunction when measured by time domain heart rate variability as opposed to healthy individuals
Measured: 1-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Aug 2023
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epilepsy; Syndrome, Seizures of Localized OnsetStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İpek Dokurel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İpek Dokurel, Ege University
- Investigators
- Muhlike Guler, MD, Study director, Balikesir Ataturk City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138847
- Sponsor's protocol ID
- levcbzepilepsy
- Acronym
- levcbz
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hennessy MJ, Tighe MG, Binnie CD, Nashef L. Sudden withdrawal of carbamazepine increases cardiac sympathetic activity in sleep. Neurology. 2001 Nov 13;57(9):1650-4. doi: 10.1212/wnl.57.9.1650.
PubMed 11706106Mukherjee S, Tripathi M, Chandra PS, Yadav R, Choudhary N, Sagar R, Bhore R, Pandey RM, Deepak KK. Cardiovascular autonomic functions in well-controlled and intractable partial epilepsies. Epilepsy Res. 2009 Aug;85(2-3):261-9. doi: 10.1016/j.eplepsyres.2009.03.021. Epub 2009 May 5.
PubMed 19409754
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Levetiracetam and Carbamazepine Impact the Autonomic Activity of Children With Self-limiting Focal Epilepsy?
- ClinicalTrials.gov ID
- NCT06138847
- Acronym / sponsor ID
- levcbz / levcbzepilepsy
- Keywords
- Heart rate variability, epilepsy, children, carbamazepine, levetiracetam, rSUDEP-7
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- İpek DokurelUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 18 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.
The goal of this cross-sectional study is to learn about autonomic cardiac profile changes in children with self-limiting focal epilepsy using levetiracetam and carbamazepine in children with self-limiting focal epilepsy syndrome. The main questions is it aims to answer are:
- Are heart rate variability and autonomic tone different among healthy controls and children with epilepsy?
- Does Levetiracetam and carbamazepine affect autonomic tone differently among children with self-limiting focal epilepsy?
Detailed description
Seventy-eight children with self-limiting focal epilepsy syndrome were enrolled in the study and were divided into two groups. Group I consisted of children with epilepsy who were only taking one type of ASM, either levetiracetam or carbamazepine. They were further subdivided into group Ia, which included patients receiving levetiracetam, and group Ib, which included patients receiving carbamazepine. Group II comprised forty-one age and sex-matched healthy children as a control group.
The pediatric neurologist utilized the clinical definition criteria of the International League Against Epilepsy to diagnose all children with self-limiting focal epilepsy syndrome.
The demographics, clinical data, neuroimaging findings, interictal scalp EEG results, and outcomes of patients' medical records were examined retrospectively. Utilizing the 10-20 system, gold cup electrodes (accompanied by conductive paste and collodium) were placed and used to acquire scalp recordings. Polygraphic derivations generally include an ECG channel, standard EEG recordings, plus an optional EMG channel.
All subjects had echocardiographic (ECHO) testing using M-mode, 2-dimensional, color, pulse, and continuous wave Doppler echocardiograms with a GE Vivid S6. A standard ambulatory electrocardiography (ECG) recording system (Cardioline Click Holter HRV Package System, version 1.4.1 Biomedical Systems, Italy) was used. All of the patients were examined during an at least 24- hour seizure-free period, and none of the patients reported seizures during the recording period and encouraged to perform their normal daily activities. Artifacts and ectopic complexes were excluded. Heart rate variability parameters used for the time domain analysis were the mean and the highest and lowest heart rates. Time domain analysis included the following: standard deviation (SD) of all normal RR intervals (SDNN, ms), SD of the average normal sinus intervals between successive heartbeats (RR intervals) for all 5 min segments of the entire recording (SDANN, ms), the root mean squares successive differences RR intervals (RMSSD, ms), the proportion of the adjacent RR intervals that differ by more than 50 ms in the 24- hour recording (pNN50, measured in percentage). While the RMSSD and pNN50 reflect vagally mediated (i.e., parasympathetic) HRV, the SDNN represents the parasympathetic and sympathetic components of the autonomic nervous system.
The rSUDEP-7 inventory was used to assess group I risk for SUDEP. The SUDEP-7 was found to be associated with a biomarker of vagus-mediated HRV(RMSSD)[25]. The revised SUDEP-7 Risk Inventory incorporates seven validated risk factors (Table 1). Since our study cohort consisted of the pediatric age group and the study design was based on patients receiving monotherapy, none of group 1 received points from the 5th and 6th items of the risk factor list.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: electroencephalogramGroup I consisted of children with epilepsy who were only taking one type of ASMs, either levetiracetam or carbamazepine |
| Group II | – | –Group II comprised forty-one age and sex-matched healthy children as a control group. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Seventy-eight children aged 5-17 years old with with self-limiting focal epilepsy syndrome were enrolled in the study and were divided into two groups. Group I consisted of children with epilepsy who were only taking one type of ASMs, either levetiracetam or carbamazepine. They were further subdivided into group Ia, which included patients receiving levetiracetam and group Ib, which included patients receiving carbamazepine. Group II comprised forty-one age and sex-matched healthy children as a control group.
Key inclusion criteria (1 listed)
- Based on the ILAE classification, all children with epilepsy are categorized as self-limiting focal epilepsy syndromes.
Key exclusion criteria (3 listed)
- had signs of organic heart disease
- had other conditions that could influence the cardiovascular and autonomic nervous systems (such as systemic lupus erythematosus, and endocrine-metabolic abnormalities)
- use regular medications that have an impact on the cardiovascular and autonomic nervous systems
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 |
|---|---|---|
| electroencephalogramPolygraphic derivations generally include an ECG channel, which is standard on EEG recordings, plus an optional EMG channel. Subsequently, the signal was recorded at 512 Hz and inspected using the standard bipolar and referential montages | Diagnostic test | Group I |
Primary outcome
children with epilepsy has autonomic disfunction
Time frame: 1-5 months
children with self-limiting focal epilepsy syndrome on monotherapy evinced parasympathetic cardiac autonomic dysfunction when measured by time domain heart rate variability as opposed to healthy individuals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 11706106Hennessy MJ, Tighe MG, Binnie CD, Nashef L. Sudden withdrawal of carbamazepine increases cardiac sympathetic activity in sleep. Neurology. 2001 Nov 13;57(9):1650-4. doi: 10.1212/wnl.57.9.1650.
- Background: PubMed 19409754Mukherjee S, Tripathi M, Chandra PS, Yadav R, Choudhary N, Sagar R, Bhore R, Pandey RM, Deepak KK. Cardiovascular autonomic functions in well-controlled and intractable partial epilepsies. Epilepsy Res. 2009 Aug;85(2-3):261-9. doi: 10.1016/j.eplepsyres.2009.03.021. Epub 2009 May 5.
- Individual participant dataSharing planned: No
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.
Muhlike Guler, MD study director
Balikesir Ataturk City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy; Syndrome, Seizures of Localized Onset, run by İpek Dokurel 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
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?
children with epilepsy has autonomic disfunction (time frame: 1-5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138847, which also lists 2 linked publications.
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 18 Nov 2023.