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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Abbott Medical Devices

Investigators

  • 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)

March 29, 2017

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimated)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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