Clinical trial NCT02963259: IPG Replacement Study (PREFERENCE-H)
Official title: Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: SJM Infinity™
SJM Brio™
Implantable pulse generator (IPG) replacement
SJM-CIP-10135
Deep brain stimulation (DBS)
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
timeFrame: 3 Months
Secondary outcomes:
measure: Number of Events Per Patient-year of Follow-up
timeFrame: 12 months after IPG replacement
measure: Incidence Rate
timeFrame: 12 months after IPG replacement
Other outcomes:
Locations:
city: Kendall
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Miami
country: United States
facility: Neuroscience Consultants
state: Florida
city: Albany
country: United States
facility: Albany Medical College at Albany Medical Ctr
state: New York
city: Gera
country: Germany
facility: Praxis Dr. Oehlwein
city: Halsbrücke
country: Germany
facility: Klinik am Tharandter Wald
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AÖR
city: Ferrara
country: Italy
facility: Az.Osp. Universitaria Ferrara
state: Cona
city: Padua
country: Italy
facility: Fondazione "Ospedale San Camillo" I.R.C.C.S
state: Veneto
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale F. Miulli
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale C. Mondino
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria S Maria della Misericordia
Study officials:
affiliation: Abbott
name: Edward Karst
role: STUDY_DIRECTOR
References: