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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration

    Other intervention

    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 intervention

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Patients with refractory epilepsyExperimental treatment 1 intervention
Group B: Healthy subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect of blue light on VNS biomarkers

Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients

Time frame
4 years
2

Effect of blue light on VNS biomarkers

Blue light increases P300 amplitude in VNS implanted patients

Time frame
4 years
3

Effect of blue light on VNS biomarkers

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

Time frame
4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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