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NCT05269862 · ClinicalTrials.gov registry record · NA
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
A NA study of Parkinson Disease, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 18
- Study locations
NCT05269862: Active NA study of Parkinson Disease, sponsored by Abbott Medical Devices.
NCT05269862 is a NA study of Parkinson Disease that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 100 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 18 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269862, a NA study of Parkinson Disease, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
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
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 |
What the registry record for NCT05269862 still lists
NCT05269862 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower).
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.
NCT05269862 lists 18 locations in 15 states (Other, Ohio, Arizona).
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.
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).
Who is sponsoring clinical trial NCT05269862?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05269862's enrollment target sits among peer trials
100 86th of 297 higher than 207 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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