ClinicalTrials.gg
Enrolling by invitationNCT03815656Updated Nov 12, 2026

Closed Loop DBS Implanted RC+S Study

An interventional study of STN alone and GPi alone in Parkinson Disease, sponsored by Dennis Turner, M.D.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Dennis Turner, M.D. · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Planned enrollment
521st of 1,256
46 · median 36
Started
2019
with 104 others
No phase
585 of 1,649
146 open now
Primary completion
2026-10
later than 90 of 384 live
Registered
932nd of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 521st largest by planned enrollment of the 1,256 interventional ones that give a count, is one of 105 that started in 2019, is one of 585 with no phase, reaches primary completion later than 90 of the 384 other live ones, and was the 932nd registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:

299 more — sign in →

All 304 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.
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:

  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.

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.

03

Conditions studied

  • Parkinson Disease

Browse trials for

Keywords

  • Deep Brain Stimulation
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Implanted RC+S arm Inclusion / Exclusion Criteria:

Inclusion Criteria:

  • able to give
  • 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, 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

Speech Rater Inclusion / Exclusion Criteria:

Inclusion Criteria:

  • able to give informed consent
  • has no hearing impairment (by self-report)
  • is a native English speaker

Exclusion Criteria:

  • is a speech therapist or clinician in a related field
  • studies linguistics / logopedics
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • 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.

    Device: STN alone · Device: GPi alone · Device: STN + GPi · Device: Closed-loop stimulation

  • No intervention
    speech rater

    blinded raters to score audio recordings of speech

Interventions

  • DeviceSTN alone

    DBS stimulation of STN alone

  • DeviceGPi alone

    DBS stimulation of GPi alone

  • DeviceSTN + GPi

    cooperative DBS stimulation of STN and GPi sites

  • DeviceClosed-loop stimulation

    adaptive DBS stimulation of STN and/or GPi sites

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline and 12 months after IPG implant

  2. 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).

    Time frame: baseline and 24 months after IPG implant

  3. 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).

    Time frame: baseline and 48 months after IPG implant

  4. 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).

    Time frame: baseline and 72 months after IPG implant

Secondary outcomes

  1. 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).

    Time frame: baseline and 12 months after IPG implant

  2. 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).

    Time frame: baseline and 24 months after IPG implant

  3. 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).

    Time frame: baseline and 48 months after IPG implant

  4. 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).

    Time frame: baseline and 72 months after IPG implant

  5. 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.

    Time frame: baseline and 12 months after IPG implant

  6. 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.

    Time frame: baseline and 24 months after IPG implant

  7. 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.

    Time frame: baseline and 48 months after IPG implant

  8. 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.

    Time frame: baseline and 72 months after IPG implant

  9. 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).

    Time frame: baseline and 12 months after IPG implant

  10. 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).

    Time frame: baseline and 24 months after IPG implant

  11. 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).

    Time frame: baseline and 48 months after IPG implant

  12. 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).

    Time frame: baseline and 72 months after IPG implant

Other outcomes

  1. Intelligibility Rating of Recorded Sentences

    Rated by volunteer blinded raters on a scale of 1 - 10, with 1 being completely unintelligible and 10 being completely intelligible.

    Time frame: 1 hour

07

Study locations

1 site
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — IPD to be shared: IPD for all participants that support the primary and secondary outcome measures listed in clinicaltrials.gov, after deidentification.

Supporting information: Informed consent form

Time frame: Data are available now through the end of funding (estimated January 2027). Additional data are updated on an annual basis.

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).

Data sharing details ↗ · dabi.loni.usc.edu

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Oct 2026, 87 months.

Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 87 months is above that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: primary completion Jan 2027 → Oct 2026 and completion Jan 2027 → Jul 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2019
First posted
Jan 24, 2019
StartActual
Jul 10, 2019
Primary completionActual
Oct 22, 2026was Jan 2027
CompletionEst.
Jul 2027was Jan 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jan 2027→Oct 22, 2026 (actual)
Nov 12, 2026
Study completion
Jan 2027→Jul 2027
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Primary completion Jan 2027→Oct 22, 2026 (now actual)
    Study completion Jan 2027→Jul 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03815656
Lead sponsor
Dennis Turner, M.D.
Responsible party
Dennis Turner, M.D. (Professor of Neurosurgery, Duke University) — Sponsor-investigator
First posted
Jan 24, 2019
Start date
Jul 10, 2019
Primary completion
Oct 22, 2026
Completion
Jul 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Dennis A Turner, M.D.
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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