Combined Deep Brain Stimulation for Parkinson's Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Deep Brain Stimulation, Gait, Electrophysiology, Parkinson Disease, PD
Eligibility Criteria
-INCLUSION CRITERIA:
i. Greater than 22 years of age
ii. Successful bilateral STN DBS implants for at least 1 year
iii. At least 30% improvement in the motor UPDRS following STN therapy, by history and record review
iv. Improved UPDRS and self assessment questionnaire following STN DBS by at least 20%, by history and record review.
v. Good STN DBS placement assessed with imaging (CT scan, MRI or fused CT-MRI imaging)
vii. Persistent gait disturbance as ascertained by abnormal performance on the time-up-and-go test compared to age-matched controls as well as preoperative evaluation with posturography and quantitative gait assessment (values compared to normal age-matched controls) at least 30% difference from age-matched controls on either measure.
vii. Persistent speech and swallowing problems as measured by a minimum score of I in items 5 and 7 of the UPDRS
viii. Evaluation by an independent movement disorders specialist who will confirm gait disturbance in the presence of STN stimulation.
EXCLUSION CRITERIA:
i. Pregnant or nursing women
ii. Cognitively impaired subjects as determined by pre-operative neuropsychology evaluation, including Mattis Dementia Rating Scale (DRS). Patients scoring below 70 on the Mattis DRS will be excluded.
iii. Depressed subjects as determined by the neuropsychology screen, including Beck Depression Inventory. Patients scoring above 20 on the Beck inventory will be excluded.
iv. Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; heart disease needing intervention; respiratory disease needing intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
v. Patients with metal objects in their body that are not MRI compatible, excluding the previous STN DBS hardware
vi. Patients who have a history of seizures, require repeated magnetic resonance imaging (MRI) scans or have had a cranial neurosurgical procedure since receiving an STN implant.