Who is eligible for clinical trial NCT05269862?

Participants must meet the protocol's inclusion criteria for Parkinson Disease. The stated age range is 21 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05269862 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2023-07-20

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation (NCT05269862)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Abbott Medical Devices

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (6 items).

Location: University of Arizona Health Sciences Center — Tucson, Arizona

Age range: 21 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (18 Sites)

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 — Mainz, Rhinela
Hospital Universitari Germans Trias I Pujol — Badalona,
Hospital Universitario de la Princesa — Madrid,
Hospital Virgen de Rocio — Seville,
Queen Elizabeth University Hospital — Glasgow, Wdbtshr

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Parkinson Disease clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗