Closed Loop DBS for Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dennis Turner, M.D.

Disqualifiers: Severe neurological injury, Depression, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the treatment of severe Parkinson's Disease by testing a new approach to deep brain stimulation (DBS). Researchers seek to determine if placing electrodes in two common brain areas, instead of one, proves more effective. The trial also explores a new adaptive system called closed-loop stimulation, which adjusts the stimulation based on brain signals. Ideal participants have Parkinson's Disease, experience side effects from levodopa medication, and are already planning to undergo DBS surgery. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance future Parkinson's treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients with medication-related side effects from levodopa, it might be possible that you can continue taking it. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this closed-loop DBS system is safe for treating Parkinson's Disease?

Research shows that deep brain stimulation (DBS) is generally safe and effective for treating Parkinson's disease. At experienced centers, DBS carries low risk. Most patients experience improvements in symptoms and quality of life.

For those considering GPi DBS, which targets the globus pallidus interna, research supports its safety and effectiveness. This well-established treatment has a strong history of managing movement problems in Parkinson's.

STN DBS, targeting the subthalamic nucleus, also maintains a good safety record. Long-term studies show it provides significant benefits, although its effectiveness may slightly decrease as Parkinson's disease progresses.

Combining STN and GPi DBS might offer a balanced treatment approach. Studies suggest this combination can be effective and well-tolerated, providing another option for improving movement problems and overall well-being.

Overall, while DBS carries some risks, such as a higher chance of hospital visits, these are minimal with careful patient selection. The treatment is generally well-tolerated and can offer significant benefits for those with severe Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about closed-loop deep brain stimulation (DBS) for Parkinson's disease because it offers a more personalized approach to managing symptoms. Unlike standard DBS, which provides continuous stimulation, closed-loop DBS adjusts the stimulation in real-time based on the patient's brain activity. This adaptive method aims to optimize symptom control while potentially reducing side effects. By targeting specific brain areas like the subthalamic nucleus (STN) and globus pallidus internus (GPi) individually or together, it offers a versatile solution to meet individual patient needs.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) effectively improves movement problems in people with Parkinson's disease. In this trial, participants will receive DBS through an implanted Medtronic RC+S IPG with dual DBS electrodes. The trial will explore different stimulation approaches: targeting the subthalamic nucleus (STN) alone, the globus pallidus internus (GPi) alone, cooperative stimulation of both STN and GPi, and adaptive, closed-loop stimulation of STN and/or GPi. Studies have found that targeting specific brain areas, like the STN or GPi, helps reduce symptoms such as tremors and movement changes. DBS in the STN has successfully reduced discomfort and unusual sensations. Stimulating the GPi also provides significant relief from movement issues. Using both STN and GPi stimulation together might offer even better results, as each area provides unique benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Dennis A Turner, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with severe Parkinson's Disease who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to consent, attend follow-ups, have levodopa-related side effects, and show at least a 30% improvement with levodopa. Excluded are those with dementia, pregnancy, unsafe surgical risks, other severe neurological diseases or conditions requiring MRIs, untreated depression, electromagnetic implants or metallic implants.

Inclusion Criteria

I have Parkinson's Disease and am eligible for brain surgery.

I experience side effects from levodopa, like sudden movements or fluctuations in my condition.

My symptoms improve by at least 30% when I take levodopa.

Exclusion Criteria

I have a severe neurological condition, but it's not Parkinson's Disease.

I am not considered safe for deep brain stimulation surgery.

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Implantation

Bilateral dual DBS electrode placement in STN and GPi, and placement of the RC+S Medtronic research implantable pulse generator (IPG)

1 week

1 visit (in-person)

Postoperative Programming and Testing

Extensive postoperative programming and testing to define clinical efficacy and develop the closed loop approach

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 months

Regular visits (in-person) at 12, 24, 48, and 72 months

What Are the Treatments Tested in This Trial?

Interventions

• Closed-loop stimulation
• GPi alone
• STN alone
• STN + GPi

Trial Overview The study tests the effectiveness of DBS electrodes implanted in two common brain areas (STN and GPi) versus just one area. It also aims to develop an adaptive DBS system that adjusts based on brain signal measurements from these electrodes.

How Is the Trial Designed?

Group I: Implanted RC+S Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Dennis Turner, M.D.

Lead Sponsor

Trials

2

Recruited

10+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

This study shows that closed loop deep brain stimulation (NclDBS) using an implanted neurostimulator is feasible and effective for treating tremor and bradykinesia in Parkinson's disease patients, improving symptoms while using significantly less electrical energy compared to traditional open loop stimulation (olDBS).

NclDBS was well-tolerated by all 13 participants, with significant improvements in bradykinesia and tremor control, indicating that this method could provide a more efficient and patient-friendly approach to managing Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual threshold neural closed loop deep brain stimulation in Parkinson disease patients. Velisar, A., Syrkin-Nikolau, J., Blumenfeld, Z., et al.[2019]

In a study of 69 patients with advanced Parkinson's disease who underwent deep brain stimulation (DBS), 53% of those with subthalamic nucleus (STN) stimulation reported ongoing adverse events (AEs) four years post-surgery, compared to 35% in the internal globus pallidus (GPi) group.

Most AEs were not severe and affected cognitive, psychiatric, and motor functions, with a notable correlation between the presence of AEs and longer disease duration and pre-existing gait and psychiatric issues in STN DBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. Hariz, MI., Rehncrona, S., Quinn, NP., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140010/

Globus Pallidus Internus (GPi) Deep Brain Stimulation for ... DBS of the GPi (GPi DBS) is an established, safe and effective method for addressing many of the motor symptoms associated with advanced PD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614509/

Comparison of the Long-Term Efficacy of Targeting ... The results indicated that the STN stimulation is effective at reducing motor symptoms during off-medication treatment for up to 15 years and ...

3. cns.org cns.org/guidelines/subthalamic-nucleus-globus-pallidus-intermus-deep-brain-stimulation-parkinson/congress-of-neurological-surgeons-systematic-revie

Guidelines on Subthalamic Nucleus and Globus Pallidus ... Deep brain stimulation (DBS) is an established therapy for improving motor symptoms and levodopa-induced dyskinesias in patients with Parkinson's disease (PD).

4. nature.com nature.com/articles/s41531-024-00689-z

Efficacy of deep brain stimulation of the subthalamic ... Following six months, subthalamic (STN)-DBS reduced sensory complaints related to parkinsonism and bodily discomfort, increasing central beta-endorphin level.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21000759

Brain Stimulation This study suggests that DBS of the posterior GPi may produce better clinical outcomes during primary Meige syndrome treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357172/

Closed-Loop Adaptive Deep Brain Stimulation in ... Concerning PD, multiple clinical studies have demonstrated that DBS was more effective than best medical therapy for moderate-to-severe PD [9] ...

7. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... Patients were not blinded to the stimulation mode. On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690827/

Deep brain stimulation in PD: risk of complications ... It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...

9. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... ... DBS treatment. These results add to the growing evidence that DBS is safe and effective when performed at experienced centers, Ramirez ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S259009352500013X

A comprehensive review of deep brain stimulation for ... In this paper, we explore the history of PD treatments with a focus on DBS, as well as the developments and advancements of the technology.