Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

Running, not enrolling · Not applicable

Conditions studied: Parkinson Disease

In brief

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 facts

Study ID

NCT05269862

Run by

Abbott Medical Devices

People needed

100

Starts

2022-03-24

Expected to finish

2024-12-01

Last updated by the study team

2023-07-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is a participant in the ADROIT study.
• Subject is over 21 years old.
• Subject is able to read and write.
• Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
• Subject has not previously been implanted with a 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.

You may not qualify if…

• Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
• Subject has 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 study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
• As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
• Subject is unable to use the Virtual Clinic feature.
• Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.

Where it is running

• 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

Full record on ClinicalTrials.gov

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