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NCT Number: NCT06304389

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

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.

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location status: Recruiting

Location contact

Inci Cakiroglu, Phd student

CONTACT

[email protected]

+32470612917

Inci Cakiroglu, Phd student

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration

Other

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.

transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration

Other

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 outcomes

  1. Effect of blue light on VNS biomarkers

    Time frame: 4 years

    Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients

  2. Effect of blue light on VNS biomarkers

    Time frame: 4 years

    Blue light increases P300 amplitude in VNS implanted patients

  3. Effect of blue light on VNS biomarkers

    Time frame: 4 years

    Blue light increases VNS (or tVNS) induced pupil dilation (in patients & healthy subjects).

Study contacts

Contact information is provided by the study sponsor or research team.

Inci cakiroglu

CONTACT

[email protected]

+32470612917

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: BLUELIGHTVNS

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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