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

Study Overview
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Brief Summary
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This is a study of subjects with the St. Jude Medical Infinity deep brain stimulation (DBS) system who undergo an MRI imaging procedure. Enrollment may occur before DBS implant, or when an MRI scan is planned in a subject with an existing implant. There will be a follow-up visit one month after the MRI procedure to document any adverse events and verify device functionality.

Detailed Description
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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.

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

Conditions
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Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia

Intervention / Treatment
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* Device: Infinity DBS System with MR Conditional labelling (Leads-only configuration)
* Device: Infinity DBS System with MR Conditional labelling (Full system configuration)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infinity DBS System with MR Conditional labelling (Leads-only configuration)<br>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. | Device: Infinity DBS System with MR Conditional labelling (Leads-only configuration)<br>* Patients will undergo MRI procedures using Leads-only configuration<br>|
| Infinity DBS System with MR Conditional labelling (Full system configuration)<br>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. | Device: Infinity DBS System with MR Conditional labelling (Full system configuration)<br>* Patients will undergo MRI procedures using Full system configuration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI-related adverse events | The primary outcome is the rate of MRI-related adverse events. | From MRI procedure through 1 month post-MRI procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infinity DBS system, ABT-CIP-1026, Deep Brain Stimulation, Magnetic resonance imaging