Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective
 surgical treatments for PD patients suffering from levodopa-induced motor complications. The
 relatively low incidence of permanent adverse effects and the potential for neuroprotection
 and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio
 of this procedure. Since neuroprotection is best applied early in the disease course when
 there are more surviving neurons, we believe that further investigation of this procedure is
 warranted. The proposed pilot study will provide the necessary data to substantiate the
 safety and tolerability of the procedure as well as provide data for the design of a
 full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and
 effective treatment to slow the progression of PD.
This pilot trial is designed specifically to collect the preliminary safety and tolerability
 data necessary to conduct a future phase III clinical trial to investigate the hypothesis
 that deep brain stimulation of the subthalamic nucleus in subjects with early Parkinson's
 will slow the progression of the disease.

 The study design is a prospective, randomized, blinded, single-center trial comparing the
 safety and tolerability of B-STN DBS + Optimal Drug Therapy (ODT) vs. (ODT) alone (control,
 standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when
 off medication).
Inclusion Criteria:

 -  Patients must have a clinical diagnosis of probable idiopathic PD.

 -  Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30%
 improvement in parkinsonian motor signs, based upon the UPDRS motor examination
 subscore, following the administration of their dopamine agonist (DA) drug(s) during
 the screening neurological examination.

 -  Hoehn and Yahr (H&Y) stage II when OFF medication.

 -  No contraindications to surgery.

 -  Age between 50 and 75 years old.

 -  Available for follow-up for four years.

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

 -  MRI within normal range for age.

 -  Levodopa or dopamine agonist therapy for greater than six months but less than or
 equal to four years.

 Exclusion Criteria:

 -  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)

 -  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).

 -  Evidence of dementia

 -  Major psychiatric disorder

 -  Previous brain operation or injury.

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

 -  Patients who have demand cardiac pacemakers or implantable cardioverter defibrillators
 (ICD's).

 -  Patients who have medical conditions that require repeat MRI scans or diathermy
 treatments.

 -  Evidence of existing dyskinesias or motor fluctuations.