Chronic Effects of DBS in Parkinson's Disease and Dystonia

Study Overview
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Brief Summary
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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.

Official Title
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Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia

Conditions
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Parkinson's Disease, Isolated Dystonia

Intervention / Treatment
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* Device: Activa PC+S


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronic brain recording<br>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. | Device: Activa PC+S<br>* Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals | To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain stimulation, cortical recording, neuroprosthesis