Parkinson's Clinical Trial
Official title:
Mobile Computing Platform to Improve Outcomes From Deep Brain Stimulation Therapy
The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision support system for individual patient management will enable considerable time savings compared to standard care. This hypothesis was formulated from pilot studies that showed dramatic decreases in DBS programming time compared to standard care for clinicians who used an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes. Study group Parkinson's patients with DBS Systems
In most cases these subjects have failed to maintain adequate control of their symptoms on
medications alone.
The Diagnosis of PD (Parkinson's Disease) and the decision to have DBS qualifies a subject
for enrollment. Subjects would be selected because they will require DBS programming.
The investigators will prospectively enroll 20 PD DBS patients at the Froedtert Movement
Disorders Center (surgical targets: subthalamic nucleus (STN) or internal segment of globus
pallidus (GPi). Post-operative care, patients will be randomized 1/1 to standard care or
using the clinical decision support system. The DBS RN will use ImageVis3D Mobile app on the
iPad to program the DBS system, this software does not interact with Froedtert imaging
systems. The study team uses identified images provided by the Froedtert PACS system, de
identifies them, adds a study code. The images are loaded into the software system and used
to identify the leads locations. The Patients will be assessed for 6 months starting with
the initial DBS programming session. Importantly, the investigators do not anticipate that
the clinical decision support tool will provide the final DBS settings, nor do we anticipate
that this approach will obviate the need for motor exams. The clinical decision support
system will help nurses choose good initial settings and then explore around those initial
settings.
The investigators will measure the time spent on DBS programming for patients in each group.
The investigators will capture programming session duration, number of programming sessions
and total time spent on DBS programming. The investigators will compare total time spent
programming for the standard care versus the intervention group.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01467960 -
Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease
|
N/A | |
| Recruiting |
NCT05516719 -
Longitudinal Investigation of I2BS in PD
|
||
| Enrolling by invitation |
NCT02670161 -
Quality Improvement and Practice Based Research in Neurology Using the EMR
|
Phase 4 | |
| Recruiting |
NCT05518617 -
Molecular and Functional Imaging in Monogenic PD.
|
||
| Recruiting |
NCT05516732 -
Serotonin Release in Premotor and Motor PD
|
||
| Terminated |
NCT02315781 -
tDCS in Parkinson's Disease With Depression
|
N/A | |
| Recruiting |
NCT06036433 -
Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease
|
N/A | |
| Completed |
NCT02271685 -
Sound Estimation and Accuracy Task
|
N/A | |
| Completed |
NCT02468804 -
Cognitive Dysfunction In Parkinson's
|
N/A | |
| Withdrawn |
NCT02561715 -
Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's
|