Clinical Evaluation of the Infinity Deep Brain Stimulation System

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Alexandra Hospital, Brisbane, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omnidirectional stimulation

Device

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.

Directional stimulation

Device

At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.

Primary outcomes

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

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

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.

Secondary outcomes

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

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

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

Time frame: 3 and 6 Months Follow-Up Visits

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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

Acronym: PROGRESS

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2022
First posted: Dec 12, 2016
Registry last updated: Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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