Deep Brain Stimulation for Parkinson's Disease Trial
Deep Brain Stimulation for Parkinson's Disease Trial
The purpose of this trial is to evaluate the effect of deep brain stimulation in the the
 globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and
 psychiatric function, and quality of life in patients with Parkinson's disease.
Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD).
 After several years of drug therapy, however, a large proportion of patients experience
 worsening of their parkinsonism and develop incapacitating motor fluctuations and
 dyskinesias. To deal with this, attention has been directed to surgical procedures, such as
 deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control
 movement, the globus pallidus (Gpi) and subthalamic nucleus (STN), has been proposed as a
 therapy for treating many of the disabling symptoms associated with PD and drug-induced side
 effects.

 The major aim of this 5-year study is to carry out a prospective, double blinded, randomized,
 clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS
 in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life
 in patients with PD. The study also will address two key issues: 1) whether there are
 differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best
 candidates for bilateral DBS.
INCLUSION:

 -  Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least
 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and
 gait/balance disorder) and a clear response to levodopa therapy.

 -  Hoeh & Yahr staging III or worse "off " medication periods.

 -  Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.

 -  Unsatisfactory clinical response to maximal medical management or previous surgical
 treatment.

 -  Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence
 varying no more than +/- twenty percent during the 30 day period.

 -  Absence of cognitive, or psychiatric or other co-morbidities that might interfere with
 the patient's ability to understand and sign the informed consent form.

 EXCLUSION:

 -  Clinically significant medical history that increases pre- / post operative
 complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…).

 -  Secondary or atypical parkinsonism as suggested by: i. History of stroke,
 encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor
 neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic
 dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar
 infracts, or iron deposits in the putamen.

 -  Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV
 criterion for dementia.

 -  Clinically significant psychiatric disorder meeting Structured Clinical Interview for
 the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.