Closed Loop DBS Implanted RC+S Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/26/2019 |
| Start Date: | May 2019 |
| End Date: | December 2021 |
| Contact: | Dennis A Turner, M.D. |
| Email: | dennis.turner@duke.edu |
| Phone: | 919-684-6706 |
Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)
This study involves patients who are already planning to have deep brain stimulation (DBS)
surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:
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.
surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:
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.
The purpose of this study is a small, first in man, clinical feasibility trial for patients
with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain
stimulation (DBS) with two goals:
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.
with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain
stimulation (DBS) with two goals:
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.
Inclusion Criteria:
- able to give informed consent
- 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:
- is not safe surgical candidate for DBS
- 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
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