Actively Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2025-09-10
34
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how exposure to blue enriched light may influence the effects of vagus nerve stimulation (VNS) in patients with refractory epilepsy. VNS is a treatment used when epilepsy does not respond well to other therapies, but many patients still have insufficient response. This study aims to explore how blue light affects biomarkers related to VNS action, which could lead to new ways to improve therapy effectiveness. Participants include patients with implanted VNS devices and healthy subjects. They will not receive drugs but will take part in experiments involving electroencephalography (brain activity recording), pupillometry (measuring pupil size), electrocardiography (heart activity recording), evoked potentials, and light administration. The study will assess how blue light impacts these physiological parameters during VNS. During the study, participants will undergo various recordings and light exposure sessions while researchers monitor brain, heart, and pupil responses. The main outcome measured is the effect of blue light on VNS biomarkers over a period of up to four years. The study is single-blinded and non-randomized, and healthy volunteers are included. Participants will be followed to understand possible changes in VNS effects with blue light exposure.
CONDITIONS
Brief Title
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with VNS implanted for at least 3 months aged 18 to 60 years
- IQ above 55 on Wechsler scale (normal status or mild cognitive impairment)
- Healthy participants aged 18 to 35 years without any neurological or psychiatric disease history
You will not qualify if you...
- Patients with implanted medical devices other than VNS
- Patients with ocular diseases
- Healthy participants with implanted medical devices
- Healthy participants with cerebral trauma
- Healthy participants with ocular diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single sessions or multiple sessions as scheduled within the study period
Participants undergo experiments involving electroencephalography, pupillometry, light administration, and transcutaneous vagus nerve stimulation to assess the effect of blue light on VNS biomarkers.
1 or more visits (in-person) depending on cohort assignment
Duration - Up to 4 years
Participants are monitored for changes in VNS biomarkers over a period of up to 4 years following experimental sessions.
Periodic visits depending on study schedule
Trial Site Locations
Total: 1 location
1
Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, Belgium, 1200
Actively Recruiting
Research Team
I
Inci cakiroglu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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