Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

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.

The ROAM-DBS study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the NeuroSphere Virtual Clinic feature (remote care) on the time needed to optimize DBS stimulation parameters after implant. The study will enroll up to 100 subjects from up to 15 centers in geographies where Abbott DBS systems with the Virtual Clinic feature are approved, which may include North America, and Europe. Subjects should be participants in the ADROIT study (NCT04071847). Subjects will be followed to a 3 month visit where the primary endpoint will be assessed. Subjects will be further followed for 1 year for final data assessment. Subjects will remain enrolled in ADROIT after the end of the ROAM study, and will complete the ADROIT 6 month and 1 year visits under that protocol. The study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.

Inclusion Criteria:

1. Subject is a participant in the ADROIT study.
2. Subject is over 21 years old.
3. Subject is able to read and write.
4. Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
5. Subject has not previously been implanted with a DBS system.
6. The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
7. Subject will have access to the Abbott Virtual Clinic system through a participating site.
8. Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
9. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
3. As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
4. Subject is unable to use the Virtual Clinic feature.
5. Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.