IPG Replacement Study (PREFERENCE-H)

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system	SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system	Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (14): Baptist Hospital of Miami
🇺🇸
Kendall, Florida, United States
Neuroscience Consultants
🇺🇸
Miami, Florida, United States
Klinik am Tharandter Wald
🇩🇪
Halsbrücke, Germany
Universitätsklinikum Leipzig AÖR
🇩🇪
Leipzig, Germany
Az.Osp. Universitaria Ferrara
🇮🇹
Ferrara, Cona, Italy
Fondazione "Ospedale San Camillo" I.R.C.C.S
🇮🇹
Padua, Veneto, Italy
Albany Medical College at Albany Medical Ctr
🇺🇸
Albany, New York, United States
Ospedale Generale Regionale F. Miulli
🇮🇹
Acquaviva delle Fonti, Italy
Ospedale dell'Angelo
🇮🇹
Mestre, Italy
IRCCS Istituto Ortopedico Galeazzi
🇮🇹
Milano, Italy
Policlinico Universitario A. Gemelli
🇮🇹
Roma, Italy
Azienda Ospedaliero-Universitaria S Maria della Misericordia
🇮🇹
Udine, Italy
Praxis Dr. Oehlwein
🇩🇪
Gera, Germany
Fondazione Istituto Neurologico Nazionale C. Mondino
🇮🇹
Pavia, Italy