30 Participants Needed

DBS Settings Optimization for Parkinson's Disease

SC
Overseen ByScott Cooper, PhD, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Deep Brain Stimulation (DBS) for Parkinson's Disease?

Deep Brain Stimulation (DBS) has been shown to be a highly effective treatment for advanced Parkinson's disease, improving symptoms and quality of life. Studies highlight the importance of careful programming and patient selection to achieve the best results, and new techniques like 'Coordinated Reset' DBS are being explored to enhance its benefits.12345

Is deep brain stimulation (DBS) generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections, lead migrations (movement of the wires), and device malfunctions, with some cases requiring additional surgery. Serious complications like permanent neurological problems occur in 4-6% of cases.678910

How is Deep Brain Stimulation (DBS) different from other treatments for Parkinson's disease?

Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to send electrical impulses, which can help manage symptoms of Parkinson's disease by altering brain activity. Unlike medications that are taken orally, DBS is a surgical treatment that offers a reversible and adjustable option, allowing for personalized settings to optimize symptom control.111121314

What is the purpose of this trial?

In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I am currently pregnant or breastfeeding.
I cannot walk by myself when my medication and devices are off.
Breaks or shorts in active contacts
See 2 more

Timeline

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

Treatment Details

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:

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Approved in United States as Deep Brain Stimulation for:
  • Advanced Parkinson's disease
  • Medically refractory tremor
  • Dystonia
  • Obsessive-compulsive disorder
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Approved in European Union as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia
  • Psychiatric conditions
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Approved in Canada as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

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

References

An update on best practice of deep brain stimulation in Parkinson's disease. [2020]
Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson's disease: case report. [2019]
Subthalamic nucleus stimulation: improvements in outcome with reprogramming. [2006]
Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease. [2022]
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. [2023]
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]
Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. [2012]
Safety considerations for deep brain stimulation: review and analysis. [2007]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Introduction to the programming of deep brain stimulators. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Multiple input algorithm-guided Deep Brain stimulation-programming for Parkinson's disease patients. [2022]
Programming of subthalamic nucleus deep brain stimulation for Parkinson's disease with sweet spot-guided parameter suggestions. [2022]
Deep brain stimulation: foundations and future trends. [2022]
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