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

Refractory Epilepsy Clinical Trial

— BLUELIGHTVNS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304389
• Other study ID #: BLUELIGHT-VNS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Inci cakiroglu
• Phone: +32470612917
• Email: inci.cakiroglu[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 2026
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Woluwe-Saint-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of blue light on VNS biomarkers	Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients	4 years
Primary	Effect of blue light on VNS biomarkers	Blue light increases P300 amplitude in VNS implanted patients	4 years
Primary	Effect of blue light on VNS biomarkers	Blue light increases VNS (or tVNS) induced pupil dilation (in patients & healthy subjects).	4 years