Decreasing Programming Time for Deep Brain Stimulation (DBS)
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | April 2014 |
| End Date: | July 2016 |
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
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
Inclusion criteria: Subjects 18 and older with a diagnosis of Parkinson's Disease that are
scheduled for Deep Brain Stimulation for control of their symptoms and are seen at the
Froedtert Neurology Outpatient Clinic.
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.
Exclusion criteria: Subjects that are not a candidate for DBS for their Parkinson's
symptoms.
We 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, we do not anticipate that our clinical decision support
tool will provide the final DBS settings, nor do we anticipate that our 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.
We will measure the time spent on DBS programming for patients in each group. We will
capture programming session duration, number of programming sessions and total time spent on
DBS programming. We will compare total time spent programming for the standard care versus
the intervention group.
scheduled for Deep Brain Stimulation for control of their symptoms and are seen at the
Froedtert Neurology Outpatient Clinic.
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.
Exclusion criteria: Subjects that are not a candidate for DBS for their Parkinson's
symptoms.
We 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, we do not anticipate that our clinical decision support
tool will provide the final DBS settings, nor do we anticipate that our 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.
We will measure the time spent on DBS programming for patients in each group. We will
capture programming session duration, number of programming sessions and total time spent on
DBS programming. We will compare total time spent programming for the standard care versus
the intervention group.
Inclusion Criteria:
Subjects 18 and older with a diagnosis of Parkinson's Disease that are scheduled for Deep
Brain Stimulation for control of their symptoms and are seen at the Froedtert Neurology
Outpatient Clinic.
Exclusion Criteria:
Patient's that are not candidates for Deep Brain Stimulation.
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