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In progress; recruitment closed · registry status

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT05269862

The registry title is shown while an English plain-language introduction is prepared. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Following participants

Start (reported actual date)
2022-03-24
Main measurements finished (planned)
2023-12
Study finished (planned)
2024-12

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — active not recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Real-world multicenter assessment of sustained clinical outcomes after digital deep brain stimulation.
This paper mentions the study ID; the relationship needs review · 2026

Participation rules recorded for this study

Age 21 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

Original description

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.

Further description from the registry

The ROAM-DBS study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the NeuroSphere Virtual Clinic feature (remote care) on the time needed to optimize DBS stimulation parameters after implant. The study will enroll up to 100 subjects from up to 15 centers in geographies where Abbott DBS systems with the Virtual Clinic feature are approved, which may include North America, and Europe. Subjects should be participants in the ADROIT study (NCT04071847). Subjects will be followed to a 3 month visit where the primary endpoint will be assessed. Subjects will be further followed for 1 year for final data assessment. Subjects will remain enrolled in ADROIT after the end of the ROAM study, and will complete the ADROIT 6 month and 1 year visits under that protocol. The study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature; Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
Phases
NA
Sponsor
Abbott Medical Devices
Start date reported by registry
2022-03-24 (actual)

Registry updated: 2023-07-21 · Status last verified by the registry submitter: 2023-07

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Arizona Health Sciences Center

Tucson, Arizona, United States

Status not reported

University of California at Davis

Sacramento, California, United States

Status not reported

University of Miami Hospital

Miami, Florida, United States

Status not reported

Rush University Medical Center

Chicago, Illinois, United States

Status not reported

Indiana University

Indianapolis, Indiana, United States

Status not reported

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Status not reported

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Status not reported

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Status not reported

Ohio State Medical

Columbus, Ohio, United States

Status not reported

Thomas Jefferson Department of Neurosurgery

Philadelphia, Pennsylvania, United States

Status not reported

Texas Movement Disorder Specialist

Georgetown, Texas, United States

Status not reported

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, Germany

Status not reported

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, N. RHIN, Germany

Status not reported

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, Germany

Status not reported

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Status not reported

Hospital Universitario de la Princesa

Madrid, Spain

Status not reported

Hospital Virgen de Rocio

Seville, Spain

Status not reported

Queen Elizabeth University Hospital

Glasgow, Wdbtshr, United Kingdom

Status not reported

Facility not reported

United States

Status not reported

Facility not reported

Germany

Status not reported

Facility not reported

Spain

Status not reported

Facility not reported

United Kingdom

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.