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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Einrichtungen der Universität Düsseldorf
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DüsseldorfGermanyUnknown status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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MainzGermanyUnknown status
Universitäts Klinikum Tübingen
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TübingenGermanyUnknown status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Virgen de Rocio
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SevilleSpainUnknown status
Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
The Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Ohio State Medical
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ColumbusUnited StatesUnknown status
Texas Movement Disorder Specialist
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GeorgetownUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Miami Hospital
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MiamiUnited StatesUnknown status
Thomas Jefferson Department of Neurosurgery
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PhiladelphiaUnited StatesUnknown status
University of California at Davis
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SacramentoUnited StatesUnknown status
University of Arizona Health Sciences Center
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.