The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.
Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
Inclusion criteria (Isolated dystonia):
Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.
Inclusion criteria (PD):
Bilateral disease (Hoehn and Yahr stage 2 or greater)
Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
UPDRS-III score off medication between 20 and 60
Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.
You CAN'T join if...
Pregnancy or breast feeding
MRI showing cortical atrophy out of proportion to age
MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension,severe diabetes, or need for chronic anticoagulation other than aspirin)
Inability to comply with study follow-up visits
Any prior intracranial surgery
Mood depression with a Beck depression inventory score of> 17 on baseline screening
Significant cognitive impairment (MoCA<25).
History of seizures
Has an active infection
Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
UCSF Surgical Movement Disorders Centeraccepting new patients San Francisco, California, 94115, United States