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ACTIVE NOT RECRUITING
NCT05269862
NA

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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

Interventions

DEVICE

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).

DEVICE

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