Does Levetiracetam and Carbamazepine Impact the Autonomic Activity of Children With Self-limiting Focal Epilepsy?

NCT06138847 | Unknown

• 1 other identifier: levcbzepilepsy
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are heart rate variability and autonomic tone different among healthy controls and children with epilepsy?
2. 2.Does Levetiracetam and carbamazepine affect autonomic tone differently among children with self-limiting focal epilepsy?

Conditions

Epilepsy; Syndrome, Seizures of Localized Onset

Keywords

Heart rate variability; epilepsy; children; carbamazepine; levetiracetam; rSUDEP-7

Outcome Measures

Primary Outcomes (1)

• 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

  1-5 months

Study Arms (2)

Group I

Group I consisted of children with epilepsy who were only taking one type of ASMs, either levetiracetam or carbamazepine

Diagnostic Test: electroencephalogram

Group II

Group II comprised forty-one age and sex-matched healthy children as a control group.

Interventions

electroencephalogram DIAGNOSTIC_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

Group I

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Based on the ILAE classification, all children with epilepsy are categorized as self-limiting focal epilepsy syndromes.

You may not qualify if:

• 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

Sponsors & Collaborators

• İpek Dokurel: lead

Study Sites (1)

Balıkesir University Medical Faculty

Merkez, Balikesi̇r, 10100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 11706106 BACKGROUND

• Mukherjee 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.

  PMID: 19409754 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Syndrome

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Muhlike Guler, MD

  Balikesir Ataturk City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: İpek Dokurel Çetin,MD

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 2, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)