Remote Care for patients with Parkinson's disease implanted with deep brain stimulation devices: A safety and feasibility Study

Abbott0 sites11 target enrollmentNovember 27, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 27, 2019

End Date

August 22, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Subject must provide written informed consent prior to any clinical investigation related procedure.
•2\.Subject will be between 21 and 75 years of age
•3\.Subject is diagnosed with Parkinson’s Disease
•4\.Subject is implanted in the subthalamic nucleus (STN) with the Abbott Infinity DBS system
•5\.Subject is willing to maintain a constant dose of anti\-Parkinson’s Disease medication indicated as best medical management for at least one month prior to study enrollment
•6\.Subject has completed at least one programming session
•7\.Subject is available for appropriate follow\-up times for the length of the study

•1\.Subject is currently participating in a clinical investigation that includes an active treatment arm
•2\.Subject underwent DBS surgery within 90 days prior to screening.
•3\.Subjects who are pregnant or nursing during the clinical investigation and follow\-up period
•4\.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 clinical investigation or to comply with follow\-up requirements, or impact the scientific soundness of the clinical investigation results.