Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
6 participants
INTERVENTIONAL
2019-07-10
2027-01-31
Brief Summary
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1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
2. to develop an adaptive DBS system using brain signals measured from these two electrodes.
Detailed Description
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1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and
2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.
The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.
The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
STN alone
DBS stimulation of STN alone
GPi alone
DBS stimulation of GPi alone
STN + GPi
cooperative DBS stimulation of STN and GPi sites
Closed-loop stimulation
adaptive DBS stimulation of STN and/or GPi sites
Interventions
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STN alone
DBS stimulation of STN alone
GPi alone
DBS stimulation of GPi alone
STN + GPi
cooperative DBS stimulation of STN and GPi sites
Closed-loop stimulation
adaptive DBS stimulation of STN and/or GPi sites
Eligibility Criteria
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Inclusion Criteria
* diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
* has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
* has off-on improvement with levodopa of at least 30%
* is available for follow-up visits for length of study
Exclusion Criteria
* has severe neurological injury or disease other than Parkinson's Disease
* has condition requiring repeated MRI scans
* has untreated, clinically significant depression
* has an electrical or electromagnetic implant
* had a prior thalamotomy or surgical ablation procedure
* has dementia interfering with ability to comply with study requirements or give informed consent
* abuses drugs or alcohol
* has a history of seizures
* has any metallic implants
* is pregnant
18 Years
75 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Duke University
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Dennis Turner, M.D.
OTHER
Responsible Party
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Dennis Turner, M.D.
Professor of Neurosurgery
Principal Investigators
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Dennis A Turner, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Mitchell KT, Schmidt SL, Cooney JW, Grill WM, Peters J, Rahimpour S, Lee HJ, Jung SH, Mantri S, Scott B, Lad SP, Turner DA. Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S. Neurosurgery. 2022 Jul 1;91(1):132-138. doi: 10.1227/neu.0000000000001957. Epub 2022 Apr 7.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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