IPG Replacement Study (PREFERENCE-H)

Parkinson Disease Clinical Trial

— PREFERENCE-H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963259
• Other study ID #: SJM-CIP-10135
• Status: Completed
• Start date: March 30, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 31, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Praxis Dr. Oehlwein	Gera
Germany	Klinik am Tharandter Wald	Halsbrücke
Germany	Universitätsklinikum Leipzig AÖR	Leipzig
Italy	Ospedale Generale Regionale F. Miulli	Acquaviva delle Fonti
Italy	Az.Osp. Universitaria Ferrara	Ferrara	Cona
Italy	Ospedale dell'Angelo	Mestre
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano
Italy	Fondazione Istituto Neurologico Nazionale C. Mondino	Pavia
Italy	Policlinico Universitario A. Gemelli	Roma
Italy	Azienda Ospedaliero-Universitaria S Maria della Misericordia	Udine
United States	Albany Medical College at Albany Medical Ctr	Albany	New York
United States	Neuroscience Consultants	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit.	The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit will be assessed.	3 Months
Secondary	Rate of safety events related to battery replacement procedures for hybrid systems	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.	12 months after IPG replacement