MedTrace Logo

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

NCT07373431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Physical activity program

Participants will engage in a structured physical exercise program conducted in small groups, 1-3 times per week, over 8-12 weeks. Each session lasts up to 1 hour and includes heart-rate-raising aerobic activities followed by a relaxation period.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Christine T Ekdahl, Associate professor · Div. Clinical Neurophysiology, Dept Clinical Sciences, Lund University & Clinical Neurophysiology, Department of Medical Imaging and Physiology, Skåne University Hospital, Lund, Sweden.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2023-06-01
Completion
2023-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373431 on ClinicalTrials.gov