N/A
Completed N=234
Clinical Evaluation of the Infinity Deep Brain Stimulation System
Source: ClinicalTrials.gov NCT02989610 ↗Enrolled (actual)
234
Serious AEs
14.5%
Results posted
Nov 2020
Primary outcomePrimary: Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) — 185 Participants — p=<0.0001
Summary
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.
Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) |
185 | <0.0001 sig |
| SECONDARY Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority) |
185 | <0.0001 sig |
| SECONDARY Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months |
25.1; 30.8 | 1.0000 |
Eligibility Criteria
Inclusion Criteria
- Subject is able to provide informed consent;
- Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN), or has received an implant of an Infinity system with bilateral lead implants in the STN;
- Subject must be available for follow-up visits.
Exclusion Criteria
- Subject is not a surgical candidate;
- In the investigator's opinion, the subject is unable to tolerate multiple programming sessions within a single setting;
- Subject is unable to comply with the follow-up schedule.
Data sourced from ClinicalTrials.gov (NCT02989610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.