Clinical trial NCT03815656: Closed Loop DBS Implanted RC+S Study
Official title: An Integrated Biomarker Approach to Personalized, Adaptive Deep Brain Stimulation in Parkinson Disease [Formerly: Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)]
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Duke University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-01-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
timeFrame: baseline and 12 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.
timeFrame: baseline and 24 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
timeFrame: baseline and 48 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.
timeFrame: baseline and 72 months after IPG implant
Secondary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant.
timeFrame: baseline and 12 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant.
timeFrame: baseline and 24 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant.
timeFrame: baseline and 48 months after IPG implant
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant.
timeFrame: baseline and 72 months after IPG implant
measure: Change in percentage of waking hours with good "on" time at 12 months after IPG implant.
timeFrame: baseline and 12 months after IPG implant
measure: Change in percentage of waking hours with good "on" time at 24 months after IPG implant.
timeFrame: baseline and 24 months after IPG implant
measure: Change in percentage of waking hours with good "on" time at 48 months after IPG implant.
timeFrame: baseline and 48 months after IPG implant
measure: Change in percentage of waking hours with good "on" time at 72 months after IPG implant.
timeFrame: baseline and 72 months after IPG implant
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.
timeFrame: baseline and 12 months after IPG implant
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.
timeFrame: baseline and 24 months after IPG implant
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.
timeFrame: baseline and 48 months after IPG implant
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.
timeFrame: baseline and 72 months after IPG implant
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Dennis A Turner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.