Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

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 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.

Inclusion Criteria:

- Diagnosis of idiopathic Parkinson's Disease

- Planning to receive a DBS device at a participating site.

- Had a DBS device implanted, at a participating site, that hasn't been programmed yet

Exclusion Criteria:

- Had a DBS device implanted at a non-participating site.

- Any previous DBS programming