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-upBaselineImplantFollow-up (post implant)
−45 to 5 days before implant0Titration 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 privacyX
Inclusion/exclusion criteriaX
Demographics and medical historyX
VNS Therapy implant/revision/explantXAs neededAs neededAs neededAs neededAs neededAs needed
VNS Therapy parameter settingsXXXXXXX
Concomitant treatments for epilepsy†XXXXX
Rescue medication useXXXXX
Seizure frequencyXXXXX
Maximum seizure-free periodXXXXX
Seizure severity/postictal severityXXXXX
Quality of lifeXXXXX
Quality of sleep (PSQI or CSHQ)‡XXXXX
Healthcare utilisationXXXXX
VNS Therapy feature use (if applicable)XXXXXX
Deaths and AEs related to VNS (if applicable)§XXXXXXX
Pregnancy reporting form (if applicable)As neededAs neededAs neededAs neededAs neededAs neededAs neededAs needed
Device deficiencies (if applicable)XXXXXXX
Study completion or withdrawalAt study exitAt study exitAt study exitAt study exitAt study exitAt 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 .