The ROAM-DBS study is a prospective, multicenter, post-market, randomized, controlled trial and will include patients implanted with the Infinity™ DBS System. This study will assess the time needed to achieve meaningful clinical benefit in patients who receive programming updates via in-clinic sessions compared to patients who receive programming updates via NeuroSphere™ Virtual Clinic sessions.
Deep Brain Stimulation Therapy
ROAM
Subject is a participant in the ADROIT study.
INCLUSION
Country
site name
Germany
Universitätsklinikum Tübingen
Germany
Universitatsmedizin der Johannes Gutenberg-Universität Mainz
Germany
Universitätsklinikum Düsseldorf
UK
Queen Elizabeth University Hospital
Spain
Hospital Universitario de La Princesa
Spain
Hospital Universitario Virgen del Rocío
Spain
Hospital Universitari Germans Trias I Pujol De Badalona
USA
Rush University Medical Center
USA
Indiana University
USA
The Cleveland Clinic Foundation
USA
Ohio State Medical
USA
USA
Swedish Neuroscience Institute
Beth Israel Deaconess Medical Center
USA
Thomas Jefferson University
USA
University of Arizona Health Sciences
USA
University of California, Davis
USA
University of Miami
Texas Movement Disorder Specialists
USA
USA
Dartmouth
STUDY
CRITERIA
Subject is over 21 years old.
Subject is able to read and write.
Subject is indicated for implant with an Infinity™ implantable pulse generator (IPG) for Parkinson’s disease.
Subject has not previously been implanted with a deep brain stimulation (DBS) system.
The treating physician believes virtual clinic is appropriate as a component in the treatment regime for this subject.
Subject will have access to the Abbott virtual clinic system through a participating site.
Subject will have internet access on their patient controller in a location suitable for a virtual clinic session.
Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Site
locations
‡
‡
‡
‡
‡
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‡
Now enrolling
patients nearing
implant for the ROAM-DBS study.
Important Safety Information: https://www.neuromodulation.abbott/us/en/important-safety-info.html
Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA
Tel: 1 651 756 2000
Neuromodulation.Abbott
Prior to using Abbott devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Rx Only
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
© 2022 Abbott. All Rights Reserved.
67291 MAT-2208781 v1.0 | Item approved for global use.
Study
Connect with us to learn more
Now enrolling
patients Nearing
Implant for the ROAM-DBS study.
Brief Summary:
Connect with us to learn more
Now enrolling
patients nearing
implant for the ROAM-DBS study.
Connect with us to learn more
