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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Movement Disorders; Dystonia; Essential Tremor; Tremor
• Intervention / Treatment: Device: Infinity DBS System with MR Conditional labelling

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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• France
  • Auverg N
    • Clermont-Ferrand, Auverg N, France, 63003
      • Chu Gabriel Montpied
• Germany
  • Bad-wur
    • Tübingen, Bad-wur, Germany, 72076
      • Universitäts Klinikum Tübingen
  • N. Rhin
    • Düsseldorf, N. Rhin, Germany, 40225
      • Medizinische Einrichtungen der Universität Düsseldorf
  • Rhinela
    • Mainz, Rhinela, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • Universitetsjukhuset I Lund
  • Uppland
    • Uppsala, Uppland, Sweden, 75185
      • Akademiska Sjukhuset
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Banner University Medical Center Tucson Campus
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Littleton, Colorado, United States, 80122
      • Neurosurgery One
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State University & Premier Health
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Washington
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infinity DBS System with MR Conditional labelling; 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.	Device: Infinity DBS System with MR Conditional labelling; Patients implanted with the Infinity DBS system with MR Conditional labeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MRI-related Adverse Events	Any adverse event that was included in the primary endpoint analysis, if it: 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; Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and; 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.	From MRI procedure through 1 month post-MRI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode	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.	Immediately after the MRI scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	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.	Immediately after the MRI scan
Rate of Successful Adjustments to the Stimulation Amplitude	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.	Immediately after the MRI scan
Rate of Successful Interrogation and Download of the IPG Parameters	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.	Immediately after the MRI scan
Rate of Successful Ability to Obtain Lead Impedance Measurements	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.	Immediately after the MRI scan

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Binith Cheeran, Abbott Medical Devices Neuromodulation

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Deep Brain Stimulation; Infinity DBS system; ABT-CIP-1026
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Dyskinesias; Movement Disorders; Parkinson Disease; Tremor; Dystonia; Essential Tremor
• Other Study ID Numbers: ABT-CIP-10262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes