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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Refractory Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients with refractory epilepsy

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

Group Type EXPERIMENTAL

electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration

Intervention Type 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.

Healthy subjects

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes