Parkinsons disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements - Patient has, or is intended to receive or be treated with, an eligible product
Exclusion criteria
Exclusion criteria: - Patient who is, or is expected to be, inaccessible for follow-up - Patient is excluded by local law - Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the Product Surveillance Registry (PSR) results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance and real-world use of DBS Percept PC marketed products and features in Japanese patients. Performance will be measured by evaluating change in the UPDRS part 3 at each follow-up visit compared to baseline and analyzed by the aDBS feature being in the on or off mode. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterize real world utilization of the aDBS feature 2. Summarize the safety profile by device, procedure, and therapy relevant events 3. Characterize product performance (freedom from product performance events) | — |
Contacts
Medtronic Japan