Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to test the use of a clinical decision support tool for
      postoperative care of Parkinson's disease patients who are treated using deep brain
      stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support
      system for individual patient management will enable considerable time savings and reduced
      burden on patients and caregivers.
    

Detailed description: 
      The proposed study will evaluate outcomes for Parkinson's disease (PD) patients who are
      treated with unilateral deep brain stimulation (DBS); patients who consent to the study will
      be randomized to standard care or the experimental group. The study will occur in two phases.

      Phase I:

      Both the standard care and experimental groups will be medically evaluated identically, but
      the programming will be different between the groups as the experimental group will be
      programmed using the iPad. Patients in the control and experimental groups will be monitored
      with the same frequency at each participating clinic. Data and safety monitoring is the
      responsibility of each participating PI and the lead PI as the protocol involves minimal risk
      or no more than a minor increase over minimal risk. We anticipate that a single nurse at each
      site will perform DBS programming.

      Phase II:

      Patients in the experimental group will be evaluated and programmed by home health nurses in
      the patient's home setting. Neurological exams in the clinic will be performed at the first
      post-operative DBS programming session and 6 months later (the proposed end of the
      experimental period for each patient). During the intervening period, DBS programming and
      patient evaluations will be performed by a home health nurse. during this phase, data and
      safety monitoring will be conducted by a DSMB, which will meet regularly to review all cases
      and ensure safety. All subjects will be recruited directly through the participating sites'
      clinic systems, and all subjects will have oral and written informed consent before
      participation in the study. We anticipate that up to two home health registered nurses (RNs)
      will be performing DBS programming in phase 2.
    

Intervention name(s): iPad-Based Clinical Support Care; Standard Clinical Care
Intervention type(s): Device; Other
Intervention description(s): Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be done with the use of a iPad-based decision support system.; Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
Other intervention name(s): iPad-Based Tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; DBS; STN; GPi; Globus pallidus; Subthalamic nucleus; Neuromodulation