NCT05269862Active, not recruiting
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Source: ClinicalTrials.gov · Last updated 21 Jul 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 Jan 2022
- Start date
- 24 Mar 2022
- Primary completion date
- Dec 2023
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Parkinson disease
- NCT number
- NCT05269862
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 24 Mar 2022 to the primary completion date, Dec 2023
- 18 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
Other illness
- 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.
Other
- Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
- 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.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Einrichtungen der Universität Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitäts Klinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Virgen de Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Ohio State Medical Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Movement Disorder Specialist Coordinator of this site? Confirm its status | Georgetown | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Miami Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Thomas Jefferson Department of Neurosurgery Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California at Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Arizona Health Sciences Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.