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IPG Replacement Study (PREFERENCE-H) | Clinical Trials | Clareo Health

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IPG Replacement Study (PREFERENCE-H)

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

NCT02963259•Abbott Medical Devices

View on ClinicalTrials.gov

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

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

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.

Locations (14)

Baptist Hospital of Miami

Kendall, Florida, United States

Neuroscience Consultants

Miami, Florida, United States

Albany Medical College at Albany Medical Ctr

Albany, New York, United States

Praxis Dr. Oehlwein

Gera, Germany

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

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Italy

Ospedale dell'Angelo

Mestre, Italy

Key Dates

Start Date

March 29, 2017

Primary Completion Date

November 29, 2019

Completion Date

January 31, 2020

Last Updated

July 8, 2024

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

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

DEVICE

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IPG Replacement Study (PREFERENCE-H)

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients