Parkinson DiseasePREFERENCE-HNCT02963259
IPG Replacement Study (PREFERENCE-H)
An observational study of Parkinson Disease, run by Abbott Medical Devices at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 29 Mar 2017to 31 Jan 2020
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have a diagnosis matching the approved indication and are being considered for an IPG replacement comprise the target population of 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 (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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Italy8 sites
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti
Az.Osp. Universitaria Ferrara
Ferrara, Cona, 44124
Ospedale dell'Angelo
Mestre
IRCCS Istituto Ortopedico Galeazzi
Milan
Fondazione "Ospedale San Camillo" I.R.C.C.S
Padua, Veneto
Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia
Policlinico Universitario A. Gemelli
Roma
Azienda Ospedaliero-Universitaria S Maria della Misericordia
Udine
United States3 sites
Albany Medical College at Albany Medical Ctr
Albany, New York, 12208
Baptist Hospital of Miami
Kendall, Florida, 33176
Neuroscience Consultants
Miami, Florida, 33176
Germany3 sites
Praxis Dr. Oehlwein
Gera
Klinik am Tharandter Wald
Halsbrücke
Universitätsklinikum Leipzig AÖR
Leipzig, 04103
About this study
Official title: Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
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.
- Conditions
- Parkinson Disease
- Being tested
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
- Keywords
- SJM Infinity™, SJM Brio™, Implantable pulse generator (IPG) replacement, SJM-CIP-10135, Deep brain stimulation (DBS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemDevice
Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (2)
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).
Measured: 12 months after IPG replacement
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.
Measured: 12 months after IPG replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start29 Mar 2017
- Primary completion29 Nov 2019
- Study completion31 Jan 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Karst, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963259
- Sponsor's protocol ID
- SJM-CIP-10135
- Acronym
- PREFERENCE-H
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2016
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
- ClinicalTrials.gov ID
- NCT02963259
- Acronym / sponsor ID
- PREFERENCE-H / SJM-CIP-10135
- Conditions
- Parkinson Disease
- Keywords
- SJM Infinity™, SJM Brio™, Implantable pulse generator (IPG) replacement, SJM-CIP-10135, Deep brain stimulation (DBS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 8 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system | – | Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemSubjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have a diagnosis matching the approved indication and are being considered for an IPG replacement comprise the target population of 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 (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemImplanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system | Device | SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system |
Primary outcome
The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
Time frame: 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.
2 secondary outcomes
Number of Events Per Patient-year of Follow-up
Time frame: 12 months after IPG replacement
Incidence Rate
Time frame: 12 months after IPG replacement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
Edward Karst study director
Abbott
14 sites in 3 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 14 sites in 3 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 9 inclusion and 5 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, United States, Germany. 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 8 Jul 2024). 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?
The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit. (time frame: 3 Months). 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 8 Jul 2024.