Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation
Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation
Outcomes study to test the hypothesis that patients first identified by community-based
 neurologists, implanted by a networked movement disorders center, and then managed by the
 same community-based neurologist will have clinical outcomes comparable to movement disorders
 centers.
The proposed outcomes study is a prospective, randomized, multicenter, single blind,
 non-inferiority clinical trial comparing the safety and efficacy of deep brain stimulation
 therapy applied in a community-based model for 62 subjects with Parkinson's disease
 appropriate for STN DBS therapy.

 Eight community-based private neurology practices will be networked to Vanderbilt University
 Medical Center (VUMC). Neurologists for each practice will attend structured educational
 programs offered by Medtronic in the identification, selection, and management of Parkinson's
 disease patients with DBS therapy. Following this educational program, each practice will
 identify subjects for implantation VUMC. Following screening and baseline visits at VUMC,
 appropriate patients will be implanted with bilateral subthalamic nucleus deep brain
 stimulating therapy. The initial post-operative programming will be done at VUMC four weeks
 after implantation. 8 subjects will then be equally randomized with half being followed for
 long-term management by the community-based neurologist. The other half will be followed at
 VUMC.

 All subsequent outpatient evaluation management of medications and deep brain stimulation
 will be managed per standard of care at the location assigned by randomization,
 community-based private neurology practice or VUMC.

 All subjects will be enrolled during the first 24 months of the study. Follow-up evaluations
 at 12 months will be performed at VUMC. Each patient identified by the community-based
 neurologist for implantation will be assessed at VUMC. This assessment will include a
 videotaped off and on UPDRS III rating, neuropsychological testing, and appropriateness as
 outlined in the patient selection educational program. Patients will be implanted by
 bilateral subthalamic nucleus deep brain stimulation therapy within 120 days of their initial
 assessment. The initial post-operative programming will be performed four weeks
 post-operatively, this is all standard of care.

 Subjects will then be randomized to be either managed by their community-based neurologist or
 at VUMC. Follow-up evaluations at 12 months will include a videotaped on and off UPDRS rating
 and neuropsychological testing, anti-parkinson medication dosages, and quality of life
 measures.
Inclusion Criteria:

 1. Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will
 be based upon the presence of at least three of four clinical features according to
 diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an
 absence of clinical features suggestive of an alternative diagnosis.

 2. Demonstrated response to dopaminergic therapy. In order to exclude patients with a
 possible alternative diagnosis, all subjects included in the study must have
 demonstrated a good response to DA drugs, defined as demonstrating at least 30%
 improvement in parkinsonian motor signs, based upon the UPDRS motor examination
 subscore, following the administration of their DA drug(s) during the screening
 neurological examination.

 3. Advanced Parkinson's disease.

 4. No contraindications to surgery.

 5. Age between 50 and 75 years old.

 6. Available for follow-up for the entire duration of the study.

 7. Informed Consent: The subject understands the risks, benefits, and alternatives to the
 study procedures and participation in the study.

 8. MRI within normal range for age

 Exclusion Criteria:

 1. Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by
 features unusual early in the clinical course: Prominent postural instability,
 freezing phenomena, or hallucinations unrelated to medications in the first 3 years
 after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other
 than restriction of upward gaze) or slowing of vertical saccades in the first year;
 severe, symptomatic dysautonomia unrelated to medications; documentation of a
 condition known to produce parkinsonism and plausibly connected to the subject's
 symptoms (such as suitably located focal brain lesions or neuroleptic use within the
 past 6 months)

 2. Uncontrolled medical condition or clinically significant medical disease that would
 increase the risk of developing pre- or postoperative complications (e.g., significant
 cardiac or pulmonary disease, uncontrolled hypertension).

 3. Evidence of dementia

 4. Major psychiatric disorder

 5. Previous brain operation or injury.

 6. Active participation in another clinical trial for the treatment of PD.

 7. Patients who have demand cardiac pacemakers or who have medical conditions that
 require repeat MRI scans.