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

Not Applicable

Recruiting

• Conditions: Refractory Epilepsy
• Interventions: Other: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration; Other: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration

• Registration Number: NCT06304389
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study Start: 2023-07-01
• Primary Completion: 2023-07-01
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration	Subjects will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.
Patients with refractory epilepsy	electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration	Patients will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.

Primary Outcome Measures

Name	Time	Method
Effect of blue light on VNS biomarkers	4 years	Blue light increases VNS (or tVNS) induced pupil dilation (in patients \& healthy subjects).

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium