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Nurse Management of Neuromodulation Therapy (DBS)

Medical College of Wisconsin logo

Medical College of Wisconsin

Status

Withdrawn

Conditions

Parkinson's

Treatments

Device: Standard of Care
Device: DBS using Clinical Support System.

Study type

Interventional

Funder types

Other

Identifiers

NCT02177149
IRB_00078062

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Standard of Care
Active Comparator group
Description:
DBS using standard of care.
Treatment:
Device: Standard of Care
DBS Clinical Support System
Experimental group
Description:
DBS using Clinical Support System.
Treatment:
Device: DBS using Clinical Support System.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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