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Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06304389
Acronym
BLUELIGHTVNS
Enrollment
34
Registered
2024-03-12
Start date
2023-07-01
Completion date
2026-04-30
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy

Brief summary

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

OTHERelectroencephalography, 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.

OTHERtranscutaneous 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.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Patients with refractory epilepsy (divided in non responders & responders), and healthy subjects

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of blue light on VNS biomarkers4 yearsBlue light increases VNS induced electroencephalogram desynchronisation in implanted patients

Countries

Belgium

Contacts

Primary ContactInci cakiroglu
inci.cakiroglu@uclouvain.be+32470612917

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026