State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University of Minnesota
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Cortical and sub-cortical brain signals using Activa PC+S
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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 Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of idiopathic Parkinson's Disease (PD).
- •Age 45-75 years
- •UPDRS III motor score (off PD medications) ≥ 25
- •Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- •Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
- •Cleared to be scanned in a 7 tesla magnet
- •Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Exclusion Criteria
- •Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
- •Evidence of secondary or atypical parkinsonism
- •Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- •Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
- •Previous pallidotomy or DBS surgery
- •Women who are currently pregnant or are breast feeding
- •MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
- •Any prior intracranial surgery
- •Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
- •History of seizures
Outcomes
Primary Outcomes
Cortical and sub-cortical brain signals using Activa PC+S
Time Frame: 12 months
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.