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
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Div. Clinical Neurophysiology, Dept Clinical Sciences, Lund University, SE-221 85 Lund, Sweden Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.