Parkinson Disease
Conditions
Keywords
SJM Infinity™, SJM Brio™, Implantable pulse generator (IPG) replacement, SJM-CIP-10135, Deep brain stimulation (DBS)
Brief summary
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.
Interventions
DEVICESJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Subject (and caregiver, if applicable) signed the approved Informed Consent; * Subject is ≥ 18 and ≤ 74 years of age; * Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion; * In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm; * Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment; * PD symptom onset is no longer than 20 years; * Subject has a Hoehn & Yahr score \<IV (on stim); * Subject with a normal cognitive function (MMSE ≥25); * Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.
Exclusion criteria
* IPG battery has less than 30% battery life at the time of consent; * Need to replace or reposition the leads or extensions during the IPG replacement procedure; * Subject had \>10 recurrent falls experienced in the 3 months prior to consent; * Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement; * Subject is unable to attend the study visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. | 3 Months | Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events Per Patient-year of Follow-up | 12 months after IPG replacement | Total number of safety events related to battery replacement surgical procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12M visit or withdrawal visit (patient-years). |
| Incidence Rate | 12 months after IPG replacement | Number of subjects who underwent IPG replacement and encountered safety events related to battery replacement surgical procedure for hybrid system divided by total subjects who underwent IPG replacement. |
Countries
Germany, Italy, United States
Participant flow
Recruitment details
The study enrolled a total of 17 subjects in 5 centers across Europe and United States between 29 March 2017 and 3 December 2018. Of the 17 enrolled subjects, 16 subjects were evaluated at the baseline visit and 12 completed the 3- and 12-month visit.
Pre-assignment details
Of the total 17 participants enrolled, 5 were withdrawn for the reasons listed and only 16 completed the baseline.
Participants by arm
| Arm | Count |
|---|---|
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | IPG Replacement not Done with Abbott Device | 2 |
| Overall Study | Subject Did Not Meet Inclusion/Exclusion Criteria | 1 |
| Overall Study | Subject Participation Terminated by Investigator | 1 |
Baseline characteristics
| Characteristic | SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System | — |
|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 8.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Italy | 12 participants | — |
| Region of Enrollment United States | 4 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| UPDRS Score UPDRS III off stimulation | 39.8 units on a scale STANDARD_DEVIATION 18.24 | — |
| UPDRS Score UPDRS III on stimulation | 23.6 units on a scale STANDARD_DEVIATION 16.1 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 17 |
| other Total, other adverse events | 1 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.
Time frame: 3 Months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System | The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. | 4 participants |
Secondary
Incidence Rate
Number of subjects who underwent IPG replacement and encountered safety events related to battery replacement surgical procedure for hybrid system divided by total subjects who underwent IPG replacement.
Time frame: 12 months after IPG replacement
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System | Incidence Rate | 0 subjects |
Secondary
Number of Events Per Patient-year of Follow-up
Total number of safety events related to battery replacement surgical procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12M visit or withdrawal visit (patient-years).
Time frame: 12 months after IPG replacement
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System | Number of Events Per Patient-year of Follow-up | 0 events per patient-year |