Clinical trial NCT03884231: A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Official title: A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Parkinson Disease
Essential Tremor
Tremor
Dystonia
Keywords: Infinity DBS system
ABT-CIP-1026
Deep Brain Stimulation
Magnetic resonance imaging
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with the Infinity DBS system with MR Conditional labeling.

Brief summary: The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.


Eligibility criteria: Inclusion Criteria:

1. Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
2. Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
4. Subject is willing and able to comply with study requirements.

Exclusion Criteria:

1. Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
4. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
5. Subject is currently participating in another clinical investigation that may confound the results of this study.

Primary outcomes:
measure: Rate of MRI-related Adverse Events
timeFrame: From MRI procedure through 1 month post-MRI procedure
Secondary outcomes:
measure: Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode
timeFrame: Immediately after the MRI scan
measure: Rate of Successful 'Turn on/Off' Functionality for the Stimulation
timeFrame: Immediately after the MRI scan
measure: Rate of Successful Adjustments to the Stimulation Amplitude
timeFrame: Immediately after the MRI scan
measure: Rate of Successful Interrogation and Download of the IPG Parameters
timeFrame: Immediately after the MRI scan
measure: Rate of Successful Ability to Obtain Lead Impedance Measurements
timeFrame: Immediately after the MRI scan
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center Tucson Campus
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Littleton
country: United States
facility: Neurosurgery One
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Shreveport
country: United States
facility: Willis-Knighton Medical Center
state: Louisiana
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Fairborn
country: United States
facility: Wright State University & Premier Health
state: Ohio
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
state: Auverg N
city: Tübingen
country: Germany
facility: Universitäts Klinikum Tübingen
state: Bad-wur
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: N. Rhin
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universität Mainz
state: Rhinela
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Lund
country: Sweden
facility: Universitetsjukhuset I Lund
state: Skane
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
state: Uppland
Study officials:
affiliation: Abbott Medical Devices Neuromodulation
name: Binith Cheeran
role: STUDY_DIRECTOR
References: