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

NCT06304389 | Recruiting

• 1 other identifier: BLUELIGHT-VNS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (3)

• Effect of blue light on VNS biomarkers

  Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients

  4 years

• Effect of blue light on VNS biomarkers

  Blue light increases P300 amplitude in VNS implanted patients

  4 years

• Effect of blue light on VNS biomarkers

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

  4 years

Study Arms (2)

Patients with refractory epilepsy

EXPERIMENTAL

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

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

Healthy subjects

EXPERIMENTAL

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

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

Interventions

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.

Patients with refractory epilepsy

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.

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Patients:
• other medical implanted devices than VNS, ocular diseases
• Helthy participants:
• medical implanted devices, cerebral trauma, ocular disease

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Evoked Potentials

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Inci cakiroglu

CONTACT

+32470612917; inci.cakiroglu@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: March 12, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: April 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

BE (1)