IPG Replacement Study (PREFERENCE-H)

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT02963259

Collaborator

(none)

Enrollment

Locations

34.1

Actual Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system

Study Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 30, 2017

Actual Primary Completion Date :

Nov 29, 2019

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit. [3 Months]
The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit will be assessed.

Secondary Outcome Measures

Rate of safety events related to battery replacement procedures for hybrid systems [12 months after IPG replacement]
The event rate will be summarized as (1) number of events per patient-year of follow up and (2) incidence rate. The number of events per patient-year of follow-up will be calculated as the total number of safety events related to battery replacement procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12 months visit or withdrawal visit (patient-years). The incidence rate (%) will be calculated as number of subjects who undergo IPG replacement and encounter safety events related to battery replacement procedure for hybrid system divided by total subjects who undergo IPG replacement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject 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 in the Investigator's opinion, is responding satisfactory to CV stimulation;
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 a St Jude Medical Brio™ DBS system for the IPG replacement;
Subject is unable to attend the study visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuroscience Consultants	Miami	Florida	United States	33176
2	Albany Medical College at Albany Medical Ctr	Albany	New York	United States	12208
3	Praxis Dr. Oehlwein	Gera		Germany
4	Klinik am Tharandter Wald	Halsbrücke		Germany
5	Universitätsklinikum Leipzig AÖR	Leipzig		Germany	04103
6	Az.Osp. Universitaria Ferrara	Ferrara	Cona	Italy	44124
7	Ospedale Generale Regionale F. Miulli	Acquaviva delle Fonti		Italy
8	Ospedale dell'Angelo	Mestre		Italy
9	IRCCS Istituto Ortopedico Galeazzi	Milano		Italy
10	Fondazione Istituto Neurologico Nazionale C. Mondino	Pavia		Italy
11	Policlinico Universitario A. Gemelli	Roma		Italy
12	Azienda Ospedaliero-Universitaria S Maria della Misericordia	Udine		Italy