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Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
NCT05269862 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DEVICE Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature
- DEVICE Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
Study Locations (18)
Other
- Hospital Universitari Germans Trias I Pujol — Badalona
- Hospital Universitario de la Princesa — Madrid
- Hospital Virgen de Rocio — Seville
Ohio
- The Cleveland Clinic Foundation — Cleveland
- Ohio State Medical — Columbus
Arizona
- University of Arizona Health Sciences Center — Tucson
California
- University of California at Davis — Sacramento
Florida
- University of Miami Hospital — Miami
Illinois
- Rush University Medical Center — Chicago
Indiana
- Indiana University — Indianapolis
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2024-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05269862
The ClinicalTrials.gov registry entry for NCT05269862 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions — of which Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05269862 reports 18 study locations spanning 15 distinct geographic areas — top geographies include Other, Ohio, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05269862 about?
NCT05269862 is a clinical study titled "Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation". 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 sub...
What is the current status of trial NCT05269862?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2022-03-24. Estimated completion is 2024-12.
What conditions does trial NCT05269862 study?
This clinical trial studies the following conditions: Parkinson Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05269862?
The interventions under investigation include: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (DEVICE), Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05269862?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05269862 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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