Gainesville, Florida 32607


Purpose:

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.


Study summary:

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 1 (in-clinic testing of iPad based decision support system) will occur from the 3rd quarter of year 1 through the 2nd quarter of year 3. Phase 2 (in-home testing by a home health nurse) will occur from the 1st quarter of year 3 through the 4th quarter of year 4. 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 the same University of Florida (UFL) and University of Utah (UU) clinics. Data and safety monitoring is the responsibility of Dr. Okun (MPI) and Dr. Lauren Schrock (Co-I) as the protocol involves minimal risk or no more than a minor increase over minimal risk and is conducted at a single site. 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 UFL and UU 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.


Criteria:

Inclusion Criteria: - Diagnosis of idiopathic Parkinson's Disease - Planning to receive a DBS device at Shands/University of Florida (UF) or the University of Utah (U of U), or - Had a DBS device implanted, at Shands/UF or U of U, that hasn't been programmed yet Exclusion Criteria: - Had a DBS device implanted at a site other than Shands/UF or U of U - Any previous DBS programming


NCT ID:

NCT02474459


Primary Contact:

Michael Olson, BA
Phone: 801-793-7883
Email: michael.olson@hsc.utah.edu


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32607
United States

Camille Swartz, BS
Phone: 352-273-5612
Email: cami.swartz@neurology.ufl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.