Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Parkinson's Disease
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Early Stage Parkinson's Disease, Parkinson's Disease, Deep Brain Stimulation, PD, DBS
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ODT
DBS+ODT
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist. B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed. Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.