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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06304389
Other study ID # BLUELIGHT-VNS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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