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NCT07373431Completed

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

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
9 Jan 2026
Start date
17 Sept 2020
Primary completion date
1 Jun 2023
Lead sponsor
Region Skane
Diseases
Epilepsy, Autism
NCT number
NCT07373431

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 17 Sept 2020 to the primary completion date, 1 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe autism spectrum disorder
  • Severe cognitive impairment
  • Active systemic inflammatory or neurodegenerative disease

Other

  • Severe ADHD
  • Traumatic brain injury within the past 6 months

Who the study is looking for

  • Children aged 10-15 years
  • Diagnosed with mild-to-moderate autism spectrum disorder and/or diagnosed with epilepsy

Age in the registry: 10 years to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Div. Clinical Neurophysiology, Dept Clinical Sciences, Lund University, SE-221 85 Lund, Sweden
Coordinator of this site? Confirm its status
LundSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.