Table 2

Protocol-specified visit schedule and assessments for participants in the CORE-VNS registry. After the first year, patients will return to the clinical site for annual visits, where all endpoint measures will be assessed. At unscheduled visits, only VNS parameter settings, concomitant treatment for epilepsy and safety data will be collected

Target follow-up	Baseline	Implant	Follow-up (post implant)
Target follow-up	−45 to 5 days before implant	0	Titration visit(s)	3 months (±45 days)	6 months (±45 days)	12/24/36 months (±45 days)	Long-term follow-up Every 12 months until 60 months or study end (±60 days)*	Unscheduled visits
Informed consent/assent/data privacy	X
Inclusion/exclusion criteria	X
Demographics and medical history	X
VNS Therapy implant/revision/explant		X	As needed	As needed	As needed	As needed	As needed	As needed
VNS Therapy parameter settings		X	X	X	X	X	X	X
Concomitant treatments for epilepsy†	X			X	X	X	X
Rescue medication use	X			X	X	X	X
Seizure frequency	X			X	X	X	X
Maximum seizure-free period	X			X	X	X	X
Seizure severity/postictal severity	X			X	X	X	X
Quality of life	X			X	X	X	X
Quality of sleep (PSQI or CSHQ)‡	X			X	X	X	X
Healthcare utilisation	X			X	X	X	X
VNS Therapy feature use (if applicable)			X	X	X	X	X	X
Deaths and AEs related to VNS (if applicable)§		X	X	X	X	X	X	X
Pregnancy reporting form (if applicable)	As needed	As needed	As needed	As needed	As needed	As needed	As needed	As needed
Device deficiencies (if applicable)		X	X	X	X	X	X	X
Study completion or withdrawal			At study exit	At study exit	At study exit	At study exit	At study exit	At study exit

*During the long-term follow-up phase, subjects will have yearly follow-up visits until 60 months post implant or until study end (whichever comes first).
†Pharmacological and non-pharmacological.
‡PSQI: Pittsburgh Sleep Quality Index for subjects ≥18 years of age at baseline/CSHQ: Children Sleep Habit Questionnaire for subjects 2–17 years of age at baseline.
§AEs possibly, probably or definitely related to VNS Therapy per investigator assessment (including those with unknown relationship).
AEs, adverse events; CSHQ, Children Sleep Habit Questionnaire; PSQI, Pittsburgh Sleep Quality Index; VNS, vagus nerve stimulation .