Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

Primary Outcomes (2)

• Primary Efficacy Endpoint: The time to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit

  The PGI consists of 2 subscales, the first rating the severity of illness (PGIS) and the second evaluating the change in illness relative to a previous status (PGIC). The PGI scale evaluates all aspects of health and assesses if there has been a change in clinical status. The scale consists of two items, one scale rating severity of illness and one rating global improvement. Severity is rated from 1=normal/not at all ill to 7= extremely ill. Global improvement is rated from 1=very much improved to 7=very much worse. The questionnaire takes approximately 5 minutes to complete. The time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions, will be compared.

  PGIC will be collected within 2 days (48 hours) after completion of each programming visit

• Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort

  The rate of programming related adverse events reported up to the Short Term (3 month) follow-up visit for the Virtual Clinic cohort will be summarized using counts and percentages.

  At 3-months after initial programming visit

Conditions