Trials Sponsors Conditions Drugs Pricing

Conditions

Parkinson Disease

Keywords

SJM Infinity™SJM Brio™Implantable pulse generator (IPG) replacementSJM-CIP-10135Deep brain stimulation (DBS)

Outcome Measures

Primary Outcomes (1)

The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
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.
3 Months

Secondary Outcomes (2)

Number of Events Per Patient-year of Follow-up
12 months after IPG replacement
Incidence Rate
12 months after IPG replacement

Study Arms (1)

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

Interventions

SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemDevice

Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (14)

Baptist Hospital of Miami

Kendall, Florida, 33176, United States

Neuroscience Consultants

Miami, Florida, 33176, United States

Albany Medical College at Albany Medical Ctr

Albany, New York, 12208, United States

Praxis Dr. Oehlwein

Gera, Germany

Klinik am Tharandter Wald

Halsbrücke, Germany

Universitätsklinikum Leipzig AÖR

Leipzig, 04103, Germany

Az.Osp. Universitaria Ferrara

Ferrara, Cona, 44124, Italy

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title: Erika Ross
Organization: Abbott

Study Officials

Edward Karst
Abbott
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

March 29, 2017

Actual (reported)

IPG Replacement Study (PREFERENCE-H)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations