Parkinson DiseasePROGRESSNCT02989610
Clinical Evaluation of the Infinity Deep Brain Stimulation System
An observational study of Parkinson Disease, run by Abbott Medical Devices at 41 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Omnidirectional stimulation and Directional stimulation
- Type of treatment
- Medical device
- How many people
- 234 participants
- Where
- 41 sitesin 8 countries
- Study dates
- 31 Jan 2017to 19 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who have a diagnosis matching the approved indication and are being considered for a DBS implant or who have been implanted with an Infinity System comprise the target population for this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
United States21 sites
Albany Medical Center
Albany, New York, 12208
University of Colorado Hospital
Aurora, Colorado, 80045
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
St. Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015
Rush University, Department of Neurological Sciences
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State Medical
Columbus, Ohio, 43210
Neurology Consultants of Dallas
Dallas, Texas, 75251
Shands at University of Florida
Gainesville, Florida, 32610
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Miami Hospital
Miami, Florida, 33136
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
New York University Langone Medical Center - Tisch Hospital
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10019
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
Abbott, Medical and Clinical Affairs
Plano, Texas, 75024
Oregon Health and Science University, Department of Neurology
Portland, Oregon, 97239
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
Germany6 sites
Carl Gustav Carus Dresden an der Technischen
Dresden, 1307
Heinrich Heine University of Düsseldorf, Department of Neurology
Düsseldorf, 40225
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
Düsseldorf
UKE Hamburg
Hamburg, 20246
Johannes Gutenberg-University of Mainz
Mainz, 55131
Klinikum der Universität Regensburg
Regensburg, 93053
Australia3 sites
Princess Alexandra Hospital
Brisbane, 4102
Royal Melbourne Hospital - City Campus
Melbourne, 3050
Westmead Hospital
Richmond, 2145
Italy3 sites
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, 27100
Azienda Ospedaliero-Universitaria S Maria della Misericordia
Udine, 33100
Poland3 sites
Copernicus Hospital, Department of Neurosurgery,
Gdansk, 80-803
Oncology Center- Marie Curie Institute
Warsaw, 02-781
Institute of Psychiatry and Neurology
Warsaw, 02-957
Spain3 sites
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital Universitario Central de Asturias, Department of Neurology,
Oviedo, 33011
Hospital Universitario Virgen del Rocío, Department of Neurology
Seville, 41013
About this study
Official title: Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator 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.
- Conditions
- Parkinson Disease
- Being tested
- Omnidirectional stimulation, Directional stimulation
- Keywords
- SJM-CIP-10061, PROGRESS, Infinity DBS, Parkinson Disease, UPDRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Directional stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Omnidirectional followed by directional DBS | 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. Receives: Device: Omnidirectional stimulation; Device: Directional stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month follow-up visit after initial programming
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 and 6 Months Follow-Up Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completion7 Aug 2019
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfons Schnitzler, MD, Principal investigator, Heinrich-Heine-Universität Düsseldorf, Institute for Clinical NeuroscienceJan Vesper, MD, Principal investigator, Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989610
- Sponsor's protocol ID
- SJM-CIP-10061
- Acronym
- PROGRESS
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2016
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
- ClinicalTrials.gov ID
- NCT02989610
- Acronym / sponsor ID
- PROGRESS / SJM-CIP-10061
- Conditions
- Parkinson Disease
- Keywords
- SJM-CIP-10061, PROGRESS, Infinity DBS, Parkinson Disease, UPDRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omnidirectional followed by directional DBS | – | Device: Omnidirectional stimulation, Device: Directional stimulationOmnidirectional 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have a diagnosis matching the approved indication and are being considered for a DBS implant or who have been implanted with an Infinity System comprise the target population for this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnidirectional stimulationAt 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. | Device | Omnidirectional followed by directional DBS |
| Directional stimulationAt 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. | Device | Omnidirectional followed by directional DBS |
Primary outcome
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.
2 secondary outcomes
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
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
Time frame: 3 and 6 Months Follow-Up Visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfons Schnitzler, MD principal investigator
Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
Jan Vesper, MD principal investigator
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Abbott Medical Devices at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Germany, Australia, Italy, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) (time frame: 3-month follow-up visit after initial programming). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.