What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, or transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration. The registry lists allocation as randomized. Vagus nerve stimulation (VNS) is an added on top of your current treatment treatment for refractory epilepsy.
They plan to enroll about 34 people at Woluwe-Saint-Lambert. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Interventions: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration
Primary outcome (registry wording): Effect of blue light on VNS biomarkers