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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Enrolling

Conditions: Refractory Epilepsy

Treatments: Other: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration; Other: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06304389

BLUELIGHT-VNS

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Patients with refractory epilepsy

Experimental group

Description:

Patients will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.

Treatment:

Other: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration

Healthy subjects

Experimental group

Description:

Subjects will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.

Treatment:

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