Status:
WITHDRAWN
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
Lead Sponsor:
University of Minnesota
Conditions:
Parkinson Disease
Parkinson
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
Primary objectives. The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of...
Detailed Description
The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of loc...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic PD.
- Age 45-75 years
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
- Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Exclusion
- Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., major 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 MR imaging (e.g., due to incompatible implanted pacemaker)
- Previous pallidotomy or DBS surgery
- Women who are currently pregnant
- MRI brain abnormalities that could indicate a neurological disorder other than idiopathic Lewy body Parkinson's disease.
- Subjects with severe or poorly controlled depression defined according to DSM-V criteria and a scored on a validated depression assessment scale.
- Epilepsy
- Immunocompromised
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
- Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04011449
Start Date
September 1 2019
End Date
December 31 2020
Last Update
April 9 2021
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455