Clinical Trial

Biomarkers for Epilepsy Development and the Effect of Physical Exercise in Children With Autism

Study acronym: ASD/EP
Completed
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Summary
This study aims to identify novel biomarkers for epilepsy development in children with autism and to evaluate the effects of physical exercise on these biomarkers and clinical outcomes. Very little is known about epilepsy biomarkers in children with autism, and the risk of developing epilepsy in this population ranges from 5% to 47%. The project focuses on potential signaling pathways, including immunological factors, synaptic proteins, circadian rhythm genes, sleep architecture, and cognitive function. Children with autism, with or without epilepsy, as well as children with epilepsy, will undergo genetic analyses (exome sequencing) of synaptic and circadian rhythm-related genes, immunological protein profiling, EEG or polysomnography, actigraphy, neuropsychological testing, and physical assessments including coordination, balance, and body awareness. Participants will also engage in a three-month structured physical exercise program. Follow-up assessments will examine the effects of exercise on seizure frequency, biomarker expression, sleep, cognition, and physical abilities. The study addresses two key research questions: 1) whether biomarkers and physiological measures correlate with seizure occurrence in children with autism, and 2) whether regular physical activity can modulate seizure frequency, biomarker expression, circadian rhythm, sleep, cognitive performance, and physical skills. The findings are expected to improve understanding of the mechanisms underlying epilepsy in autism and inform potential interventions.
Trial Details
NCT Number NCT07373431
Lead Sponsor Region Skane
Conditions Epilepsy, Autism Spectrum Disorder
Enrollment 50 participants
Start Date 2020-09-17
Primary Completion 2023-06-01 (estimated)
Study Completion 2023-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-28