DBS: Nurse Management of Neuromodulation Therapy
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care DBS using standard of care. |
Device: Standard of Care
Patients in the standard of care arm will have their DBS programmed per standard of care which is testing multiple settings and looking for symptom relief through a trial and error process.
|
| Experimental: DBS Clinical Support System DBS using Clinical Support System. |
Device: DBS using Clinical Support System.
The DBS RN (Registered Nurse) will use ImageVis3D Mobile app on the iPad to program the DBS system, this software does not interact with 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 the investigators anticipate that the 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.
|
Outcome Measures
Primary Outcome Measures
- Measure the effectiveness of DBS decision support system in an established clinic. [6 months]
Patients will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS, motor section) by a blinded rater (Dr. Hiner, movement disorders neurologist). Patients will be tested in their best "On" state (e.g.on medication, on stimulation). The investigators will compare UPDRS-III scores for the standard care versus the intervention group. The UPDRS, Motor section is performed at each visit. Patient-Reported Outcomes The study team will capture patient-reported QOL (Quality of Life) using PDQ-39 (Parkinson 's Disease Questionnaire. The PDQ-39 is a validated, widely used scale completed by the patient, and is used to assess health-related quality of life in this cohort (Jenkinson, Peto, Fitzpatrick, Greenhall, & Hyman, 1995). Patients will fill out rating scales using a web-based form on an iPad or workstation during each clinic visit.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical College of Wisconsin
Investigators
- Principal Investigator: Christopher Butson, PhD, Medical College of Wiscosnisn
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB_00078062