AdaptiveDBS (aDBS) Japan Registry

JRCT ID: jRCT1042210061

Registered date:31/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Parkinsons disease
• Date of first enrollment: 09/10/2021
• Target sample size: 120
• Study type: Observational

Outcome(s)

• Primary Outcome: 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 Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hidaka Kazuhiro