Clinical Research Directory
Browse clinical research sites, groups, and studies.
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Sponsor: Abbott Medical Devices
Summary
The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-03-24
Completion Date
2024-12
Last Updated
2023-07-21
Healthy Volunteers
No
Conditions
Interventions
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature
Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted in-clinic (not using the Virtual Clinic feature).
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted using Virtual Clinic or in-clinic as appropriate.
Locations (18)
University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of California at Davis
Sacramento, California, United States
University of Miami Hospital
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State Medical
Columbus, Ohio, United States
Thomas Jefferson Department of Neurosurgery
Philadelphia, Pennsylvania, United States
Texas Movement Disorder Specialist
Georgetown, Texas, United States
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, N. RHIN, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, Germany
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Virgen de Rocio
Seville, Spain
Queen Elizabeth University Hospital
Glasgow, Wdbtshr, United Kingdom