Deep Brain Stimulation for Parkinson's Disease

(MOPSO PIGD Trial)

Overseen By Johanna Caskey, BA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Neurological, Musculoskeletal, Dementia, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for Parkinson's disease using deep brain stimulation (DBS), which sends electrical signals to specific brain areas. Researchers are testing different settings on the DBS device to better target brain pathways and manage symptoms. Participants will have either the subthalamic nucleus (STN) or globus pallidus (GP) targeted. Suitable candidates have Parkinson’s, already use a specific DBS device, and have undergone a brain scan and CT as part of their treatment. This study could help refine DBS settings for more personalized and effective therapy. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to pioneering advancements in Parkinson's therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this deep brain stimulation is safe for Parkinson's disease?

Research shows that both types of deep brain stimulation (DBS) being studied—STN DBS and GP DBS—are generally safe for people with Parkinson's disease.

For STN DBS, studies have found that side effects are rare and usually brief. In a group of 72 patients, no serious problems like death, muscle weakness, or seizures were reported, suggesting that STN DBS is well-tolerated.

For GP DBS, research has shown it to be safe and effective in improving movement symptoms in advanced Parkinson's disease. This type of DBS is already a well-known treatment for these symptoms, indicating its safety.

In summary, both STN DBS and GP DBS have been found to be safe and effective in treating Parkinson's disease symptoms, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Deep Brain Stimulation (DBS) for Parkinson's Disease because it offers a targeted approach to managing symptoms. Unlike common treatments like medications that increase dopamine levels, DBS involves implanting electrodes in specific brain areas—namely, the subthalamic nucleus (STN) and globus pallidus (GP). These electrodes send electrical impulses to precisely control abnormal brain activity without the systemic side effects of drugs. This method could offer more consistent symptom relief and improve quality of life for patients with Parkinson's Disease.

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

This trial will compare two types of deep brain stimulation (DBS) for Parkinson's disease: one targeting the subthalamic nucleus (STN) and the other targeting the globus pallidus (GP). Research has shown that STN DBS effectively treats Parkinson’s disease, reducing symptoms like tremors and stiffness, with benefits lasting for years. Patients report feeling more comfortable and experiencing a better quality of life. Evidence also supports using DBS in the GP, which improves movement and reduces tremors. This method is known for its safety and effectiveness in managing Parkinson's symptoms over time. Both STN and GP DBS offer promising results for people with Parkinson’s, providing long-term relief from challenging symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Cooper, MD, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for Parkinson's Disease patients with bilateral deep brain stimulation (DBS) who've had a specific type of MRI and CT scan, and have been using their neurostimulators for at least 3 months. It excludes those with dementia, pregnancy, or other conditions affecting movement beyond PD.

Inclusion Criteria

I have had a high-resolution MRI scan before my brain surgery.

Bilateral DBS

Directional DBS electrode system

Exclusion Criteria

Pregnancy

Dementia

I have had brain surgery that wasn't for deep brain stimulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo DBS stimulation with settings optimized for specific pathways using particle swarm optimization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GP DBS
• STN DBS

Trial Overview

The study tests personalized stimulator settings in DBS patients to improve gait and balance issues. Using advanced imaging techniques, the trial aims to optimize electrical current delivery to targeted brain areas within approved safety limits.

How Is the Trial Designed?

Group I: STN DBS Experimental Treatment 1 Intervention

Patients with implanted STN DBS leads will be allocated to this group for DBS stimulation of the STN, within FDA-approved limits and labeling, for symptoms of PD.

Group II: GP DBS Experimental Treatment 1 Intervention

Patients with implanted GP DBS leads will be allocated to this group for DBS stimulation of the GP, within FDA-approved limits and labeling, for symptoms of PD.

GP DBS is already approved in United States, European Union for the following indications:

Approved in United States as GP DBS for:

• Parkinson's disease
• Dyskinesias
• Motor fluctuations

Approved in European Union as GP DBS for:

• Parkinson's disease
• Advanced Parkinson's symptoms
• Motor complications

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) in the subthalamic nucleus (STN) was found to be more effective in reducing Parkinson's disease symptoms compared to stimulation in the globus pallidus internus (GPi), with a significant difference in improvement rates (54.5% vs. 43.1%).

DBS of the GPi was particularly effective in reducing abnormal involuntary movements (AIMs), which were not affected by STN stimulation, suggesting that GPi and STN may have different mechanisms of action in treating Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the subthalamic nucleus compared with the globus pallidus internus in patients with Parkinson disease. Peppe, A., Pierantozzi, M., Bassi, A., et al.[2013]

Deep brain stimulation (DBS) of both the globus pallidus and subthalamic nucleus provides immediate benefits in reducing motor symptoms of Parkinson's disease, observable as early as 15 minutes after stimulation is turned on.

The effects of DBS are sustained for up to 6 hours, indicating its effectiveness in managing all major motor features of Parkinson's disease in the studied patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and time course of deep brain stimulation of the globus pallidus and subthalamus on motor features of Parkinson's disease. Hristova, A., Lyons, K., Tröster, AI., et al.[2019]

A patient with Parkinson's disease who had existing bilateral GPi deep brain stimulation (DBS) for dyskinesia underwent additional bilateral STN DBS to address persistent motor fluctuations, which had not improved with GPi stimulation.

The addition of STN DBS successfully increased the patient's 'on' time, reduced her medication needs, and improved her overall motor scores, demonstrating the potential for combined DBS targeting in complex cases of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral subthalamic deep brain stimulation after bilateral pallidal deep brain stimulation for Parkinson's disease. Deogaonkar, M., Monsalve, GA., Scott, J., et al.[2013]

Deep brain stimulation (DBS) for Parkinson's disease can significantly improve motor symptoms, but patients often have unrealistic expectations, leading to dissatisfaction even when clinical improvements are observed.

Postoperative complications, such as worsening speech, gait, and cognition, as well as potential impulse control disorders, highlight the need for careful management and realistic communication about DBS outcomes to enhance patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in PD Patient Management After DBS: A Pragmatic Review. Rossi, M., Bruno, V., Arena, J., et al.[2023]

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]

In a study comparing 128 patients with Parkinson's disease who underwent either GPi or STN deep brain stimulation, no significant differences in cognitive and psychiatric outcomes were observed three years post-surgery, indicating both procedures have similar effects on these aspects.

Measures of social functioning and marital satisfaction were also comparable between the two groups, suggesting that the choice between GPi and STN DBS may not be influenced by cognitive or psychiatric side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and psychiatric outcome 3 years after globus pallidus pars interna or subthalamic nucleus deep brain stimulation for Parkinson's disease. Boel, JA., Odekerken, VJ., Schmand, BA., et al.[2018]

In a study involving 10 patients with advanced Parkinson's disease, both deep brain stimulation (DBS) of the globus pallidus internus (GPi) and the subthalamic nucleus (STN) showed similar improvements in motor symptoms, with about 40% improvement in Unified PD Rating Scale scores after 12 months.

GPi stimulation was more effective than STN stimulation in improving motor scores when patients were on L-dopa, and it also improved axial symptoms, while STN stimulation reduced the need for L-dopa medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pallidal and subthalamic nucleus deep brain stimulation for advanced Parkinson's disease: results of a randomized, blinded pilot study. Burchiel, KJ., Anderson, VC., Favre, J., et al.[2022]

In a 5 to 6 year follow-up study of 51 advanced Parkinson's disease patients, both subthalamic nucleus (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) significantly improved motor function, with STN showing a greater improvement of 45.4% compared to 20.0% for GPi.

While both DBS methods improved daily activities and reduced dyskinesias, the STN group experienced more adverse events, suggesting that GPi DBS may be a safer option with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of a multicenter study on subthalamic and pallidal stimulation in Parkinson's disease. Moro, E., Lozano, AM., Pollak, P., et al.[2023]

Bilateral high-frequency continuous stimulation of the subthalamic nucleus can effectively replace ineffective globus pallidus stimulation in patients with severe Parkinson's disease, demonstrating a successful alternative treatment.

The study highlights the reversibility of deep brain stimulation therapy, suggesting that targeting the subthalamic nucleus may provide better long-term relief for patients compared to the globus pallidus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of long-term pallidal stimulation corrected by subthalamic stimulation in PD. Houeto, JL., Bejjani, PB., Damier, P., et al.[2019]

Citations

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