Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration.
- Who it may be relevant to
- Registry conditions: Refractory Epilepsy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.
Interventions
- Other electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration
Recording of the electrical activity of the brain, of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters. - Other transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration
Transcutaneous vagus nerve stimulation will be performed in helathy subjects, as well as the recording of the electrical activity of the brain, and of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters.
Primary outcome measures
- Effect of blue light on VNS biomarkers [Time frame: 4 years]
- Effect of blue light on VNS biomarkers [Time frame: 4 years]
- Effect of blue light on VNS biomarkers [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
Patients:
VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment)
healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)
Exclusion criteria
Patients:
other medical implanted devices than VNS, ocular diseases
Helthy participants:
medical implanted devices, cerebral trauma, ocular disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- Cliniques Universitaires Saint Luc — Woluwe-Saint-Lambert
Identifiers
NCT: NCT06304389 · BLUELIGHT-VNS