Status:
ACTIVE_NOT_RECRUITING
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Parkinson Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 (re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
- 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.
- As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05269862
Start Date
March 24 2022
End Date
December 1 2024
Last Update
July 21 2023
Active Locations (18)
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1
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85274
2
University of California at Davis
Sacramento, California, United States, 95817
3
University of Miami Hospital
Miami, Florida, United States, 33136
4
Rush University Medical Center
Chicago, Illinois, United States, 60612