IPG Replacement Study (PREFERENCE-H)

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis Dr. Oehlwein, Gera, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system

Device

Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system

Primary outcomes

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.

Secondary outcomes

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).
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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems

Acronym: PREFERENCE-H

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Nov 15, 2016
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed