None listed
Conditions
Brief summary
The primary purpose of this investigation is to determine the safety of the remote care paradigm where we evaluate if a clinician can reasonably assess a patient’s Parkinson’s Disease symptoms and adjust their therapy over a mobile platform. We hypothesize that this is safe mode of adjusting therapy.
Interventions
Up to thirty-two PD patients will be enrolled in a prospective, double-blind study design in Australia. They will randomly be assigned to remote care paradigm (n = 16) or standard of care protocol (n = 16). For the first session, all subjects will be connected to an experienced programmer remotely via a mobile platform (programmer is off-site) and be in the room (in-clinic) with an expert programmer. The subject will be evaluated first by the in-person clinician and then by the remote clinician
Up to thirty-two PD patients will be enrolled in a prospective, double-blind study design in Australia. They will randomly be assigned to remote care paradigm (n = 16) or standard of care protocol (n = 16). For the first session, all subjects will be connected to an experienced programmer remotely via a mobile platform (programmer is off-site) and be in the room (in-clinic) with an expert programmer. The subject will be evaluated first by the in-person clinician and then by the remote clinician while interacting over the mobile platform. During the programming sessions, subjects will be evaluated for PD symptoms and adjustments will be made to their programming parameters accordingly. Both clinicians (neurologist and affiliated nurse practitioner) will be unblinded to the random assignment and the clinician corresponding to the subject’s cohort will save programming parameters on to the subject’s Implantable Pulse Generator (IPG). A third assessor(in-clinic) will determine programming effectiveness acutely (20 mins post session) and over time (3 weeks post first follow-up programming session). Both the subject and the assessor will be blinded to whether the program is saved by the in-person clinician or by the remote clinician. Subjects participating in this clinical investigation will be followed for 3 months (first follow-up programming session, 3-week assessment and 3-month follow-up). Each session is expected to last less than an hour. At each of these sessions, subjects will be assessed for their symptoms and if needed, the clinician will make appropriate adjustments to the programming parameters. The total duration of the clinical investigation is expected to be 9 months.
Sponsors
Abbott
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed