Clinical Evaluation of the Infinity Deep Brain Stimulation System (PROGRESS)

Abbott

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Directional stimulation; Device: Omnidirectional stimulation

Study type: Observational

Funder types: Industry

Identifiers

NCT02989610

SJM-CIP-10061

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

234 participants in 1 patient group

Omnidirectional followed by directional DBS

Description:

Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary end point is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit. In this Observational study design, all interventions here are therapeutic interventions that are part of the standard of care, rather than assigned as part of an interventional study.

Treatment:

Device: Omnidirectional stimulation

Device: Directional stimulation