15 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Parkinson's Disease

(BOG DBS Trial)

JC
Overseen ByJohanna Caskey, BA
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called deep brain stimulation (DBS) to improve walking problems in people with Parkinson's disease. Researchers aim to determine if a specific technique can fine-tune DBS settings to enhance walking ease and consistency. Participants must have Parkinson’s disease and have undergone DBS surgery at least three months prior. This trial excludes those unable to walk even with assistance or those with significant walking issues from other conditions. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in Parkinson's care.

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

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease. Studies have found that patients often experience significant improvements in movement and balance after receiving DBS. For example, many patients report fewer falls and enhanced physical abilities, indicating that the treatment is well-tolerated.

DBS has been used for a long time to treat Parkinson's, and most patients do not experience serious side effects. Some might notice slight changes in thinking, but these are rare and minor. Long-term studies also support DBS as a safe choice, showing it might even help patients live a bit longer.

The FDA has approved DBS for treating Parkinson's symptoms, which adds confidence in its safety. Overall, DBS is a promising option for improving the quality of life for people with Parkinson's.12345

Why are researchers excited about this trial?

Unlike other treatments for Parkinson's Disease, which often include medications like levodopa or dopamine agonists, Deep Brain Stimulation (DBS) offers a surgical option that directly targets brain activity. DBS involves implanting electrodes in specific brain areas to modulate abnormal signals, potentially reducing symptoms like tremors and rigidity more effectively. Researchers are excited about DBS because it provides a more personalized approach, allowing for adjustments in stimulation to meet individual patient needs, and it may also reduce the need for high doses of medication, minimizing side effects.

What evidence suggests that deep brain stimulation is effective for Parkinson's disease?

Studies have shown that deep brain stimulation (DBS) can improve movement problems in people with Parkinson's disease, such as tremors and stiffness. Research indicates that targeting specific brain areas, like the subthalamic nucleus (STN) or globus pallidus (GP), has effectively improved movement control. Early findings suggest that DBS can significantly enhance walking ability in Parkinson's patients. While there is much hope, results can vary, and ongoing research aims to refine the method for better outcomes. In this trial, all participants will receive DBS, and the study explores whether adjusting DBS settings using a method called Bayesian optimization can further improve walking in Parkinson's patients.678910

Who Is on the Research Team?

SC

Scott Cooper, MD, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who already have a deep brain stimulator (DBS) in the subthalamic nucleus or globus pallidus, and whose device has been active and stable for at least 3 months.

Inclusion Criteria

At least 3 months after lead implantation
I have had deep brain stimulation in the STN or GP.
I have been diagnosed with Parkinson's disease.

Exclusion Criteria

Breaks or shorts in active contacts
IPG battery nearing end of life (in patients with primary-cell IPGs)
I have trouble understanding and agreeing to medical studies on my own.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Bayesian optimization of DBS settings to improve gait symptoms, with approximately 30 treadmill walking tests to determine optimal settings.

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

  • Deep Brain Stimulation

Trial Overview

Researchers are testing if using a method called Bayesian optimization can help adjust DBS settings to improve walking (step length) in Parkinson's patients. The study involves measuring gait while changing DBS settings.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

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data.org - Data and AI for mission

data.org coordinates across sectors to support and advance visionary—yet practical—solutions to drive impact through data and AI.

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Data.gov Home - Data.gov

The Home of the U.S. Government's Open Data. Here you will find data, tools, and resources to conduct research, develop web and mobile applications, design data ...

Data | An Open Access Journal from MDPI

The journal publishes in two sections: a section on the collection, treatment and analysis methods of data in science; a section publishing descriptions of ...

Annual Progress Reports - Data Dashboard and Downloads

Raw data from 2018 onwards available for download from the California Open Data Portal. Housing Element Implementation and APR Dashboard. The dashboard below ...

Triple perspective: assessing deep brain stimulation outcomes ...

Patients, caregivers, and neurologists reported an average improvement of about 60% in the psychological domain and over 75% in the physical ...

Considering Deep Brain Stimulation

Although DBS is not a cure for Parkinson's and does not stop the progression of the disease, it can dramatically reduce some PD motor symptoms and significantly ...

Consensus Statements on Deep Brain Stimulation in ...

Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), consistently showing superior outcomes over ...

Has Deep Brain Stimulation Changed the Very Long‐Term ...

For a median observational period of 14 years, patients treated with DBS were at lower risk of experiencing recurrent falls (hazard ratio = 0.57; 95% confidence ...

DBS Outcomes | Brain Institute

Most studies have found that DBS can be much more effective than medication to treat movement-related symptoms. On this page, you will find highlights of this ...