A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

Completed

Conditions: Parkinson Disease
Dystonia
Tremor
Movement Disorders
Essential Tremor

Interventions: Device: Infinity DBS System with MR Conditional labelling (Leads-only configuration)
Device: Infinity DBS System with MR Conditional labelling (Full system configuration)

Registration Number: NCT03884231

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: This study will be conducted as an international, multicenter,observational, prospective, single-arm, post-market clinical follow-up (PMCF). The study will evaluate the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure is performed according to the approved guidance.

The study will enroll approximately 74 subjects at up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling is approved, including the European Union and the United States. Subjects who have a leads-only configuration or a full system configuration will participate in the study. Subjects may be enrolled when an MRI procedure is prescribed per standard of care.

Each subject will be limited to one MRI procedure during the course of the study. Data collected include MRI parameters and any adverse events that occur during or after the procedure. There will be an office visit to document any adverse events and verify device functionality for all subjects one month (30 days ± 14 days) post-MRI follow-up visit after the initial MRI procedure is performed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

Inclusion Criteria

Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
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.
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.
Subject is willing and able to comply with study requirements.

Exclusion Criteria

Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
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.
Subject is currently participating in another clinical investigation that may confound the results of this study.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infinity DBS System with MR Conditional labelling (Leads-only configuration)	Infinity DBS System with MR Conditional labelling (Leads-only configuration)	The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain. The leads-only configuration consists of at least one implanted lead protected with a lead protection boot, as well as an optional cranial burr hole cover. Any leads must be completely implanted with the surgical incision closed.
Infinity DBS System with MR Conditional labelling (Full system configuration)	Infinity DBS System with MR Conditional labelling (Full system configuration)	The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain. The full system configuration consists of at least one IPG, one lead, one extension, and an optional cranial burr hole cover. All devices must be completely implanted with the surgical incision closed.

Primary Outcome Measures

Name	Time	Method
Rate of MRI-related Adverse Events	From MRI procedure through 1 month post-MRI procedure	Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

Secondary Outcome Measures

Name	Time	Method
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful MRI mode 'turn on/off' functionality of the MRI mode was assessed.
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful 'turn on/off' functionality for the stimulation was assessed.
Rate of Successful Adjustments to the Stimulation Amplitude	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful adjustments to the stimulation amplitude was assessed.
Rate of Successful Interrogation and Download of the IPG Parameters	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful interrogation and download of the IPG parameters was assessed.
Rate of Successful Ability to Obtain Lead Impedance Measurements	Immediately after the MRI scan	Secondary endpoints were evaluated after the MRI scan on subjects, who were scanned with a full system configuration. Rate of successful ability to obtain lead impedance measurements was assessed.

Trial Locations

Locations (16): Universitatsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪
Mainz, Rhinela, Germany
Banner University Medical Center Tucson Campus
🇺🇸
Tucson, Arizona, United States
Neurosurgery One
🇺🇸
Littleton, Colorado, United States
Wright State University & Premier Health
🇺🇸
Fairborn, Ohio, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Inland Northwest Research
🇺🇸
Spokane, Washington, United States
CHU Gabriel Montpied
🇫🇷
Clermont-Ferrand, Auverg N, France
Universitäts Klinikum Tübingen
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Tübingen, Bad-wur, Germany
Medizinische Einrichtungen der Universität Düsseldorf
🇩🇪
Düsseldorf, N. Rhin, Germany
Hospital Universitario de la Princesa
🇪🇸
Madrid, Spain
Universitetsjukhuset I Lund
🇸🇪
Lund, Skane, Sweden
Akademiska sjukhuset
🇸🇪
Uppsala, Uppland, Sweden
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Willis-Knighton Medical Center
🇺🇸
Shreveport, Louisiana, United States
Robert Wood Johnson University Hospital
🇺🇸
New Brunswick, New Jersey, United States