NCT03815656Enrolling by invitation
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)]
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 17 Jan 2019
- Start date
- 10 Jul 2019
- Primary completion date
- Jan 2027
- Lead sponsor
- Dennis Turner, M.D.
- Diseases
- Parkinson disease
- NCT number
- NCT03815656
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 10 Jul 2019 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- is not safe surgical candidate for DBS
- has an electrical or electromagnetic implant
- had a prior thalamotomy or surgical ablation procedure
- abuses drugs or alcohol
- has any metallic implants
Other illness
- has severe neurological injury or disease other than Parkinson's Disease
- has condition requiring repeated MRI scans
- has dementia interfering with ability to comply with study requirements or give informed consent
- has a history of seizures
Other
- has untreated, clinically significant depression
- is pregnant
- Speech Rater Inclusion / Exclusion Criteria:
- is a speech therapist or clinician in a related field
- studies linguistics / logopedics
Who the study is looking for
- 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
Criteria the registry did not label
- Implanted RC+S arm Inclusion / Exclusion Criteria:
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.