Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)
Parkinson's Disease, Isolated Dystonia
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring deep brain stimulation, cortical recording, neuroprosthesis
Eligibility Criteria
Inclusion Criteria(both groups):
- Ability to give informed consent for the study
- 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):
- Age 22-75
- 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):
- Age 30-75
- 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.
Exclusion Criteria (both groups):
- 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
- Immunocompromised
- 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.
Sites / Locations
- UCSF Surgical Movement Disorders Center
Arms of the Study
Arm 1
Experimental
chronic brain recording
This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.