Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06304389

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

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Experimental Sessions

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

Long-term Monitoring

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

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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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