Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic featureAbbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
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.
Study 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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject is a participant in the ADROIT study.
2. Subject is over 21 years old.
3. Subject is able to read and write.
4. Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
5. Subject has not previously been implanted with a DBS system.
6. The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
7. Subject will have access to the Abbott Virtual Clinic system through a participating site.
8. Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
9. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Exclusion Criteria:
1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. 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.
3. As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
4. Subject is unable to use the Virtual Clinic feature.
5. Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.
Primary outcome measure(s)
Primary Efficacy Endpoint: The time to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit — PGIC will be collected within 2 days (48 hours) after completion of each programming visit The PGI consists of 2 subscales, the first rating the severity of illness (PGIS) and the second evaluating the change in illness relative to a previous status (PGIC). The PGI scale evaluates all aspects of health and assesses if there has been a change in clinical status. The scale consists of two items, one scale rating severity of illness and one rating global improvement. Severity is rated from 1=normal/not at all ill to 7= extremely ill. Global improvement is rated from 1=very much improved to 7=very much worse. The questionnaire takes approximately 5 minutes to complete. 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 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, will be compared.
Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort — At 3-months after initial programming visit The rate of programming related adverse events reported up to the Short Term (3 month) follow-up visit for the Virtual Clinic cohort will be summarized using counts and percentages.
Trial sites (18)
Facility
City
Region
Status
University of Arizona Health Sciences Center
Tucson
Arizona
University of California at Davis
Sacramento
California
University of Miami Hospital
Miami
Florida
Rush University Medical Center
Chicago
Illinois
Indiana University
Indianapolis
Indiana
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
The Cleveland Clinic Foundation
Cleveland
Ohio
Ohio State Medical
Columbus
Ohio
Thomas Jefferson Department of Neurosurgery
Philadelphia
Pennsylvania
Texas Movement Disorder Specialist
Georgetown
Texas
Universitäts Klinikum Tübingen
Tübingen
Bad-wur
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
N. RHIN
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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