Parkinson Disease
Conditions
Keywords
SJM-CIP-10061, PROGRESS, Infinity DBS, Parkinson Disease, UPDRS
Brief 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.
Interventions
DEVICEOmnidirectional stimulation
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.
DEVICEDirectional stimulation
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.
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority) | 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 | 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. |
Countries
Australia, Belgium, Germany, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
This prospective, blinded-subject, blinded-evaluator, observational, multi-center 12-month post-market clinical follow-up study study enrolled a total of 234 participants between January 2017 and January 2019 at 37 sites in Europe, the U.S. and Australia. Of which 82 participants completed 36 months follow-up visit.
Participants by arm
| Arm | Count |
|---|---|
| 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 the following three months up to 6 months, unless not tolerated.
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead. | 234 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Departure of PI from Site | 8 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | PI Left, Study Closing | 1 |
| Overall Study | Site Discontinued Participation in the Study | 1 |
| Overall Study | Subject Non-Compliance | 2 |
| Overall Study | Subject Participation Terminated by Investigator | 6 |
| Overall Study | System Explant | 3 |
| Overall Study | System Revision | 2 |
| Overall Study | Unable to Complete Visit Due to PI Leaving University | 1 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Omnidirectional Followed by Directional DBS | — |
|---|---|---|
| Age, Continuous | 61.7 Years STANDARD_DEVIATION 8.4 | — |
| Duration of Parkinson Symptoms | 11.2 Years STANDARD_DEVIATION 4.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 15 Participants | — |
| Region of Enrollment Belgium | 1 Participants | — |
| Region of Enrollment Germany | 62 Participants | — |
| Region of Enrollment Italy | 4 Participants | — |
| Region of Enrollment Poland | 19 Participants | — |
| Region of Enrollment Spain | 43 Participants | — |
| Region of Enrollment United States | 90 Participants | — |
| Sex: Female, Male Female | 77 Participants | — |
| Sex: Female, Male Male | 157 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 234 |
| other Total, other adverse events | 32 / 234 |
| serious Total, serious adverse events | 34 / 234 |
Outcome results
Primary
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
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omnidirectional Followed by Directional DBS | Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) | 185 Participants |
Comparison: Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.p-value: <0.0001Clopper-Pearson method
Secondary
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
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnidirectional Followed by Directional DBS | Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months | Omnidirectional stimulation (3 months) | 25.1 Score on a scale | Standard Deviation 12.8 |
| Omnidirectional Followed by Directional DBS | Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months | Directional stimulation (6 months) | 30.8 Score on a scale | Standard Deviation 14 |
Comparison: Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used.p-value: 1t-test, 1 sided
Secondary
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
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omnidirectional Followed by Directional DBS | Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority) | 185 Participants |
Comparison: Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.p-value: <0.0001Clopper-Pearson method