Parkinsons

Trial Status: Plan to open Mid November

Protocol: Early Deep Brain Stimulation
Principle Investigator: Michael Sermersheim
Sub Investigators: Charles Simchak – Xabier Beristain
Synopsis: Will establish if patients relatively early in their disease process treated with DBS will have neuroprotection and thus slowed disease progression.

Inclusion:

1. Confirmed idiopathic PD diagnosis for at least 5 years based upon the presence of at least 3 of the cardinal motor signs (bradykinesia, rigidity, resting tremor, asymmetric onset)
2. Age 55 – 70 (#1c)
3. Documented response to L-Dopa
4. Ability to comprehend English.
5. Hoehn Yar of 2.5-3

Exclusion:

1. Significant history of psychological / cognitive disease
2. Chronic disease affecting gait, speech, or mentation
3. Terminal disease with life expectancy less than 5 years
4. Presence of Severe Heart Disease
5. Presence of Bleeding disorders
6. Cerebral Vascular malformations.
7. Brain anomalies that prevent safe implantation.
8. Presence of any implanted device that would inhibit performing MRIs
9. Presence of confounding disease processes such as, but not necessarily limited to: Hx drug abuse - Hx ETOH – Essential tremor – MSA – Hx psychiatric disorder. Etc as established by medical records / family / patient history.
10. Hx of atypical / secondary Parkinsonism; i.e.
    • suspicious PD etiology such as CVA, encephalitis toxin / neruoepileptics exposure.
    • Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction
    • MRI scan with evidence of significant brain atrophy, lacunar infarcs, or iron deposits in the putamen.
11. Presence of any neurological / medically unstable condition.