Clinical Evaluation of the Infinity Deep Brain Stimulation System

Abbott Medical Devices234 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

234

Conditions

Parkinson Disease

Interventions

Omnidirectional stimulationDEVICE

At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (41)

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Shands at University of Florida

Gainesville, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Rush University, Department of Neurological Sciences

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)

Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.

Time frame: 3-month follow-up visit after initial programming

Secondary Outcomes

Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)

Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.

Time frame: 3-month follow-up visit after initial programming

Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months

Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.

Time frame: 3 and 6 Months Follow-Up Visits