Parkinson DiseaseNCT03815656
Closed Loop DBS Implanted RC+S Study
A study testing STN alone, GPi alone and STN + GPi in people with Parkinson Disease, run by Dennis Turner, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- STN alone, GPi alone and STN + GPi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- able to give informed consent
- has no hearing impairment (by self-report)
- is a native English speaker
Who cannot join
- 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
Show all 14Show fewer
- 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
- Speech Rater Inclusion / Exclusion Criteria:
- is a speech therapist or clinician in a related field
- studies linguistics / logopedics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this 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)]
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.
Read the 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.
In a separate cohort, we are enrolling healthy volunteers as blinded raters of audio recordings made by people with Parkinson's disease and without Parkinson's disease to study whether different features of speech patterns are specific to PD and whether there are measurable differences in these speech features when PD participants are on different deep brain stimulation settings. These ratings do not contribute to the primary or secondary endpoints of this study.
Study design details listed in this record are specific to the Implanted RC+S clinical trial cohort.
- Conditions
- Parkinson Disease
- Being tested
- STN alone, GPi alone, STN + GPi, Closed-loop stimulation
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN aloneDevice
DBS stimulation of STN alone
GPi aloneDevice
DBS stimulation of GPi alone
STN + GPiDevice
cooperative DBS stimulation of STN and GPi sites
Closed-loop stimulationDevice
adaptive DBS stimulation of STN and/or GPi sites
| Study group | Role | What they receive |
|---|---|---|
| Implanted RC+S | Experimental | 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. Receives: Device: STN alone; Device: GPi alone; Device: STN + GPi; Device: Closed-loop stimulation |
| speech rater | No intervention | blinded raters to score audio recordings of speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: baseline and 72 months after IPG implant
Secondary outcomes (12)
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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: baseline and 72 months after IPG implant
Change in percentage of waking hours with good "on" time at 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.
Measured: baseline and 12 months after IPG implant
Change in percentage of waking hours with good "on" time at 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.
Measured: baseline and 24 months after IPG implant
Change in percentage of waking hours with good "on" time at 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.
Measured: baseline and 48 months after IPG implant
Change in percentage of waking hours with good "on" time at 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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: baseline and 72 months after IPG implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start10 Jul 2019
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dennis Turner, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Duke University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Dennis Turner, M.D., Duke University
- Investigators
- Dennis A Turner, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815656
- Sponsor's protocol ID
- Pro00100982
- Other IDs
- UH3NS103468, UH3NS129898
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2019
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD to be shared: IPD for all participants that support the primary and secondary outcome measures listed in clinicaltrials.gov, after deidentification.
Publications
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.
PubMed 35383660
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)]
- ClinicalTrials.gov ID
- NCT03815656
- Acronym / sponsor ID
- Pro00100982
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dennis Turner, M.D.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Duke University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
In a separate cohort, we are enrolling healthy volunteers as blinded raters of audio recordings made by people with Parkinson's disease and without Parkinson's disease to study whether different features of speech patterns are specific to PD and whether there are measurable differences in these speech features when PD participants are on different deep brain stimulation settings. These ratings do not contribute to the primary or secondary endpoints of this study.
Study design details listed in this record are specific to the Implanted RC+S clinical trial cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanted RC+S | Experimental | Device: STN alone, Device: GPi alone, Device: STN + GPi, Device: Closed-loop stimulationImplanted 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. |
| speech rater | No intervention | –blinded raters to score audio recordings of speech |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN aloneDBS stimulation of STN alone | Device | Implanted RC+S |
| GPi aloneDBS stimulation of GPi alone | Device | Implanted RC+S |
| STN + GPicooperative DBS stimulation of STN and GPi sites | Device | Implanted RC+S |
| Closed-loop stimulationadaptive DBS stimulation of STN and/or GPi sites | Device | Implanted RC+S |
Primary outcome
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).
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).
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).
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).
12 secondary outcomes
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 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 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 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 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 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 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 with good "on" time at 72 months after IPG implant.
Time frame: 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 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 35383660Mitchell 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.
- Individual participant dataSharing planned: Yes. IPD to be shared: IPD for all participants that support the primary and secondary outcome measures listed in clinicaltrials.gov, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis A Turner, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STN alone, GPi alone and STN + GPi in people with Parkinson Disease, run by Dennis Turner, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.