IPG Replacement Study (PREFERENCE-H) (PREFERENCE-H)

January 22, 2024 updated by: Abbott Medical Devices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gera, Germany
        • Praxis Dr. Oehlwein
      • Halsbrücke, Germany
        • Klinik am Tharandter Wald
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR
  • Italy
      • Acquaviva delle Fonti, Italy
        • Ospedale Generale Regionale F. Miulli
      • Mestre, Italy
        • Ospedale dell'Angelo
      • Milano, Italy
        • IRCCS Istituto Ortopedico Galeazzi
      • Pavia, Italy
        • Fondazione Istituto Neurologico Nazionale C. Mondino
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria S Maria della Misericordia
    • Cona
      • Ferrara, Cona, Italy, 44124
        • Az.Osp. Universitaria Ferrara
    • Veneto
      • Padua, Veneto, Italy
        • Fondazione "Ospedale San Camillo" I.R.C.C.S
  • United States
    • Florida
      • Kendall, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Miami, Florida, United States, 33176
        • Neuroscience Consultants
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College at Albany Medical Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Events Per Patient-year of Follow-up
Time Frame: 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).
12 months after IPG replacement
Incidence Rate
Time Frame: 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.
12 months after IPG replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Edward Karst, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings