Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
The purpose of the ROAM-DBS study is to compare 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 ADROIT 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. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.
• Subject is a participant in the ADROIT study.
• Subject is over 21 years old.
• Subject is able to read and write.
• Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
• Subject has not previously been implanted with a DBS system.
• The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
• Subject will have access to the Abbott Virtual Clinic system through a participating site.
• Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
• Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.