- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815656
Closed Loop DBS Implanted RC+S Study
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)]
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:
- 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
- to develop an adaptive DBS system using brain signals measured from these two electrodes.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
DBS stimulation of STN alone
DBS stimulation of GPi alone
cooperative DBS stimulation of STN and GPi sites
adaptive DBS stimulation of STN and/or GPi sites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
Time Frame: baseline and 12 months after IPG implant
|
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 12 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
The scores from four subscales (1.
Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score.
Total scores range from 0 (no disability) to 199 (total disability).
|
baseline and 12 months after IPG implant
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.
Time Frame: baseline and 24 months after IPG implant
|
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 24 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
The scores from four subscales (1.
Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score.
Total scores range from 0 (no disability) to 199 (total disability).
|
baseline and 24 months after IPG implant
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
Time Frame: baseline and 48 months after IPG implant
|
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 48 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
The scores from four subscales (1.
Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score.
Total scores range from 0 (no disability) to 199 (total disability).
|
baseline and 48 months after IPG implant
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.
Time Frame: baseline and 72 months after IPG implant
|
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 72 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
The scores from four subscales (1.
Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score.
Total scores range from 0 (no disability) to 199 (total disability).
|
baseline and 72 months after IPG implant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: baseline and 12 months after IPG implant
|
Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 12 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
|
baseline and 12 months after IPG implant
|
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.
Time Frame: baseline and 24 months after IPG implant
|
Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 24 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
|
baseline and 24 months after IPG implant
|
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.
Time Frame: baseline and 48 months after IPG implant
|
Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 48 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
|
baseline and 48 months after IPG implant
|
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.
Time Frame: baseline and 72 months after IPG implant
|
Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 72 months after IPG implant.
The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease.
Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
|
baseline and 72 months after IPG implant
|
Change in percentage of waking hours with good "on" time at 12 months after IPG implant.
Time Frame: baseline and 12 months after IPG implant
|
Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
|
baseline and 12 months after IPG implant
|
Change in percentage of waking hours with good "on" time at 24 months after IPG implant.
Time Frame: baseline and 24 months after IPG implant
|
Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
|
baseline and 24 months after IPG implant
|
Change in percentage of waking hours with good "on" time at 48 months after IPG implant.
Time Frame: baseline and 48 months after IPG implant
|
Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
|
baseline and 48 months after IPG implant
|
Change in percentage of waking hours with good "on" time at 72 months after IPG implant.
Time Frame: baseline and 72 months after IPG implant
|
Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
|
baseline and 72 months after IPG implant
|
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.
Time Frame: baseline and 12 months after IPG implant
|
Change in PDQ-39 score compared to pre-surgery baseline.
The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life.
The PDQ-39 is divided into 8 dimensions (1.
Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort).
The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
|
baseline and 12 months after IPG implant
|
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.
Time Frame: baseline and 24 months after IPG implant
|
Change in PDQ-39 score compared to pre-surgery baseline.
The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life.
The PDQ-39 is divided into 8 dimensions (1.
Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort).
The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
|
baseline and 24 months after IPG implant
|
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.
Time Frame: baseline and 48 months after IPG implant
|
Change in PDQ-39 score compared to pre-surgery baseline.
The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life.
The PDQ-39 is divided into 8 dimensions (1.
Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort).
The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
|
baseline and 48 months after IPG implant
|
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.
Time Frame: baseline and 72 months after IPG implant
|
Change in PDQ-39 score compared to pre-surgery baseline.
The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life.
The PDQ-39 is divided into 8 dimensions (1.
Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort).
The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
|
baseline and 72 months after IPG implant
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dennis A Turner, M.D., Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00100982
- UH3NS103468 (U.S. NIH Grant/Contract)
- UH3NS129898 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Supporting Information (informed consent form) is available on clinicaltrials.gov.
IPD are available by request at the Data Archive for the BRAIN Initiative (dabi.loni.usc.edu). Requests for access will be evaluated through the end of grant funding (estimated January 2027).
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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