VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
NCT03953768
Autoimmune Diseases, Autonomic Dysfunction
Louisville, Kentucky, United States
View Trial DetailsNCT Number: NCT07834983
Epilepsy is a chronic neurological disorder characterized by recurrent unprovoked seizures, but it can also affect the autonomic nervous system and cardiovascular function. Certain anti-epileptic medications and seizure activity may influence cardiac rhythm, beat-to-beat heart rate variability (HRV), and ventricular repolarization (measured by the QT interval). The primary purpose of this study is to evaluate autonomic tone and cardiac electrical conduction in children with epilepsy receiving anti-epileptic drugs by measuring time-domain HRV and the corrected QT (QTc) interval, comparing patients on monotherapy, patients on polytherapy, and healthy controls.
A total of 60 children aged 1 to 18 years will be enrolled across three groups: 20 children with epilepsy receiving single-drug therapy (monotherapy), 20 children with epilepsy receiving two or more medications (polytherapy), and 20 healthy children serving as controls.
All participants will complete non-invasive assessments during a single visit, including:
* Collection of clinical and demographic data (age, sex, epilepsy duration, and medication details) * A standard 12-lead electrocardiogram (ECG) to measure the QT interval and calculate the QTc using Fridericia's formula * A 5-minute continuous resting ECG recorded in a supine position after 10 minutes of quiet rest to calculate time-domain HRV parameters (SDNN, RMSSD, and pNN50)
The findings aim to detect early autonomic or electrophysiological alterations, aiding in the understanding of cardiac safety in pediatric epilepsy management.
Trial opening soon.
Get Notified1 year–18 year
All sexes
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Corrected QT interval (reported in milliseconds) measured from a standard 12-lead ECG recorded at standard velocity and amplitude. The QT interval is measured in lead V5 (or lead II if lead V5 is unsuitable) across three consecutive cardiac cycles and averaged. QTc is calculated using Fridericia's formula: QTc = QT / RR^(1/3).
Assiut University
Other
Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy Receiving Anti-Epileptic Drugs
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