DBS Settings Optimization for Parkinson's Disease

Overseen By Johanna Caskey, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Inability to walk, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different settings for Deep Brain Stimulation (DBS) in people with Parkinson's Disease to observe their effects on symptoms. Researchers aim to understand how two specific brain pathways respond to various stimulation settings. Suitable participants have Parkinson's, have undergone DBS for at least three months, and can walk under certain conditions. The goal is to determine if adjusting DBS settings can improve life for Parkinson's patients. As an unphased trial, participants contribute to innovative research that could enhance treatment options for Parkinson's Disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this neurostimulator setting is safe for Parkinson's disease patients?

Research has shown that Deep Brain Stimulation (DBS) for Parkinson's disease is generally safe. Studies have found that DBS often improves movement and causes fewer side effects than other treatments. For instance, patients in one study reported feeling better overall with DBS. DBS has been used for a long time in people with Parkinson's and helps reduce the need for other medications.

A study that followed DBS patients for five years found it safe for long-term use. While no treatment is without risks, many people with Parkinson's disease tolerate DBS well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to optimize the settings for Deep Brain Stimulation (DBS) in treating Parkinson's Disease. While traditional treatments like medication focus on managing symptoms, DBS directly targets the brain's electrical activity to reduce symptoms like tremors and stiffness. The key here is fine-tuning DBS settings for each patient, potentially enhancing its effectiveness and minimizing side effects compared to standard approaches. This personalized approach might lead to better symptom control and improved quality of life for patients.

What evidence suggests that these DBS settings could be effective for Parkinson's disease?

Research has shown that Deep Brain Stimulation (DBS) improves symptoms in people with Parkinson's disease. Studies have found that DBS can reduce symptoms like tremors and stiffness by 50% or more. One study highlighted that DBS is especially helpful during the moderate stages of Parkinson's, offering lasting benefits. Long-term results also indicate that patients feel better overall with DBS. Although DBS does not stop the disease from progressing, it can greatly enhance the quality of life for many patients. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for Parkinson's Disease patients aged 18-85 with bilateral DBS implants, a cognitive score of at least 23, and who are at least 3 months post-implant. They must have had specific MRI and CT imaging done. Pregnant or nursing women, those with nearly depleted IPG batteries, inability to walk without stimulation, or gait issues not caused by PD cannot join.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease.

My mental ability to understand and decide on treatment is confirmed by tests.

I have had a 7T MRI and a post-op CT scan as required.

Exclusion Criteria

I am currently pregnant or breastfeeding.

Breaks or shorts in active contacts

IPG battery nearing end of life (in patients with primary-cell IPGs)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two different neurostimulator settings for two weeks to compare effects on Parkinson's symptoms

2 weeks

Multiple sessions including laboratory testing

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ADL and QOL scales

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation (DBS)

Trial Overview The study tests two different DBS settings in Parkinson's patients to see how they affect symptoms. The settings differ in their activation of neural pathways between the Globus Pallidus and Pedunculopontine Nucleus.

Deep Brain Stimulation (DBS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Advanced Parkinson's disease
• Medically refractory tremor
• Dystonia
• Obsessive-compulsive disorder

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Psychiatric conditions

Approved in Canada as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A semi-automatic algorithm-guided programming (AgP) approach for Deep Brain Stimulation (DBS) in Parkinson's disease showed significant improvement in motor symptoms compared to no therapy, with a median improvement in Unified Parkinson's Disease Rating Scale III scores.

While both AgP and standard of care (SoC) DBS settings provided similar clinical outcomes, AgP required testing of many more settings (37 on average) to find optimal stimulation, indicating it may offer a more tailored approach to DBS programming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple input algorithm-guided Deep Brain stimulation-programming for Parkinson's disease patients. Gülke, E., Juárez Paz, L., Scholtes, H., et al.[2022]

Effective management after deep brain stimulation (DBS) surgery for conditions like Parkinson's disease relies heavily on the skills of movement disorder specialists in adjusting stimulation parameters and medications.

The authors propose a standardized algorithm for selecting DBS stimulation parameters, which can simplify the complex settings and improve patient outcomes through better clinical and neurophysiological management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the programming of deep brain stimulators. Volkmann, J., Herzog, J., Kopper, F., et al.[2023]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Deep brain stimulation (DBS) can improve motor function and quality of life in patients with Parkinson's disease when used alongside traditional medication, particularly for those whose symptoms are not well-controlled by medication alone.

However, while DBS offers significant benefits, it also comes with a higher risk of adverse events compared to pharmacotherapy, highlighting the need to carefully consider the risks and benefits before opting for this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. Sharma, A., Szeto, K., Desilets, AR.[2012]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease, but it requires careful adherence to specific guidelines when performing MRI to avoid serious complications.

A case study highlighted a permanent neurological injury caused by improper use of MRI in a patient with a DBS device, emphasizing the critical need for following manufacturer guidelines to ensure patient safety during imaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson's disease: case report. Henderson, JM., Tkach, J., Phillips, M., et al.[2019]

In a study of 44 patients with advanced Parkinson's disease who had been receiving deep brain stimulation (DBS) for an average of 3.5 years, 54.6% showed significant improvements in their symptoms after a neurologist expert reprogrammed their DBS settings and adjusted their medications.

The reprogramming led to a 15.0% improvement in Unified Parkinson's Disease Rating Scale scores for daily living and a 25.9% improvement in motor function, while also allowing for a 25.9% reduction in antiparkinsonian drug dosages, demonstrating the importance of personalized postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus stimulation: improvements in outcome with reprogramming. Moro, E., Poon, YY., Lozano, AM., et al.[2006]

Deep Brain Stimulation (DBS) is an established treatment for Parkinson's Disease, and standardized postoperative programming can enhance symptom relief and quality of life for patients.

An expert consensus developed by Chinese specialists aims to standardize DBS programming, which is expected to improve the overall management of patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease. Chen, S., Gao, G., Feng, T., et al.[2022]

Low-intensity Coordinated Reset (CR) deep brain stimulation (DBS) showed significant motor improvements in a non-human primate model of Parkinson's disease, with benefits that persisted for up to two weeks after treatment, indicating a potential for long-lasting therapeutic effects.

In contrast to traditional DBS, which had limited carry-over effects, CR DBS demonstrated progressive enhancements in motor function with each treatment session, suggesting it may be a safer and more efficient option for managing Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinated Reset Deep Brain Stimulation of Subthalamic Nucleus Produces Long-Lasting, Dose-Dependent Motor Improvements in the 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine Non-Human Primate Model of Parkinsonism. Wang, J., Nebeck, S., Muralidharan, A., et al.[2023]

A new sweet spot-guided algorithm was developed to suggest optimal stimulation parameters for Deep Brain Stimulation (DBS) in 24 Parkinson's disease patients, aiming to reduce the time and discomfort associated with traditional trial-and-error methods.

The algorithm showed a significant improvement in suggesting the best contact for stimulation compared to reconstruction-guided methods, with an accuracy of 41%, while the accuracy for lead levels was 56%, indicating potential for enhanced patient-specific treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programming of subthalamic nucleus deep brain stimulation for Parkinson's disease with sweet spot-guided parameter suggestions. Nordenström, S., Petermann, K., Debove, I., et al.[2022]

Deep brain stimulation (DBS) is a highly effective treatment for advanced Parkinson's disease, with its success relying on careful patient selection and individualized targeting of stimulation parameters.

Recent advancements in DBS hardware allow for more focused stimulation, which can improve clinical outcomes, but also require healthcare providers to adapt to the increased complexity in programming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on best practice of deep brain stimulation in Parkinson's disease. Hartmann, CJ., Fliegen, S., Groiss, SJ., et al.[2020]

Deep brain stimulation (DBS) is a safe and reversible treatment option for neurological conditions like essential tremor, Parkinson's disease, and severe obsessive-compulsive disorder, showing significant functional and structural changes in the brain.

DBS induces neuroplasticity through various mechanisms, including increased striatal dopamine release and expression of trophic factors, which may provide neuroprotective effects, particularly in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: foundations and future trends. Aum, DJ., Tierney, TS.[2022]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) significantly improved motor symptoms in a 44-year-old woman with Parkinson's disease, but also caused uncontrollable laughter, highlighting the potential for neurobehavioral side effects.

The use of directional electrodes allowed for more precise stimulation, which helped to minimize undesirable side effects while optimizing motor improvement, suggesting that careful programming and electrode placement are crucial for effective DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. Alonso-Frech, F., Fernandez-Garcia, C., Gómez-Mayordomo, V., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ... Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...

2. 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 used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

Five-Year Outcomes from Deep Brain Stimulation of the ... This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.

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

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

5. neurologyadvisor.com neurologyadvisor.com/features/deep-brain-stimulation-parkinson-disease/

Deep Brain Stimulation in Parkinson Disease Treatment Clinical outcomes with DBS have been consistently favorable across PD symptoms. “Modern DBS treatment typically achieves a 50% or greater ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3002606/

Deep Brain Stimulation in Parkinson's Disease - PMC In different randomized controlled trials DBS showed a better functional outcome with fewer side effects [Esselink et al. 2004; Schuurman et al. 2000] and ...

7. bmjmedicine.bmj.com bmjmedicine.bmj.com/content/3/1/e000705

Deep brain stimulation for Parkinson's disease: systematic ... Our results showed that participants receiving deep brain stimulation were likely to reduce their dose of antiparkinsonian drugs. This finding ...