5000 Participants Needed

Deep Brain Stimulation for Parkinson's Disease

Recruiting at 20 trial locations
DK
RJ
AC
CM
Overseen ByCleo Mertz
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of Deep Brain Stimulation (DBS) on individuals with certain conditions by analyzing past patient records. DBS involves implanting a device that sends electrical signals to the brain, helping manage symptoms of conditions such as Parkinson's disease, essential tremor (uncontrollable shaking), and dystonia (muscle contractions). The trial aims to understand the real-world effects of this treatment for each condition. Individuals previously treated with or eligible for a DBS system might be suitable participants. As an unphased trial, this study provides an opportunity to contribute to understanding DBS's impact on various conditions.

Do I need to stop my current medications for this trial?

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

What prior data suggests that Deep Brain Stimulation is safe for Parkinson's Disease, Essential Tremor, and Dystonia?

Research has shown that Deep Brain Stimulation (DBS) is generally safe for treating movement disorders such as Parkinson's disease, essential tremor, and dystonia. Studies have found that DBS can improve movement in people with Parkinson's, though it might slightly increase hospital visits if patients are not carefully selected. Most reported side effects are mild and manageable.

For essential tremor, DBS has improved symptoms and quality of life. Common side effects include speech difficulties, numbness, mild weakness, and headaches, but these are usually mild.

In dystonia, DBS is considered safe and effective, providing significant improvements in quality of life. Over 20 years of experience supports the long-term safety of DBS for these conditions.12345

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) is unique because it directly targets brain regions responsible for movement disorders like Parkinson's Disease, Essential Tremor, and Dystonia, offering a more tailored intervention than broadly acting medications such as levodopa or propranolol. Unlike standard drug therapies that can have widespread effects and diminishing returns over time, DBS provides continuous electrical stimulation, which can be adjusted to the patient's specific needs, potentially leading to better symptom control. Researchers are excited about DBS because it allows for real-time modulation of brain activity, which could improve motor function and quality of life for patients who don't fully respond to medications.

What evidence suggests that Deep Brain Stimulation is effective for Parkinson's Disease, Essential Tremor, and Dystonia?

This trial will evaluate Deep Brain Stimulation (DBS) for various conditions. Research has shown that DBS effectively treats Parkinson's Disease, with studies finding significant movement improvement, with some patients experiencing a 49–71% reduction in symptoms. For participants with Essential Tremor, DBS significantly reduces tremors, aiding in better movement control. In those with Dystonia, DBS has improved muscle control and reduced involuntary movements, easing daily activities. Overall, DBS offers a valuable treatment option for these conditions, providing hope for symptom relief and improved quality of life.678910

Who Is on the Research Team?

NB

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Neuromodulation Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

Must be previously treated with or eligible for implantation with a deep brain stimulation system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Review

Retrospective review of de-identified patient records to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS)

Not applicable

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Parkinson's DiseaseExperimental Treatment1 Intervention
Group II: Essential TremorExperimental Treatment1 Intervention
Group III: DystoniaExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Deep Brain Stimulation for:
🇪🇺
Approved in European Union as Deep Brain Stimulation for:
🇨🇦
Approved in Canada as Deep Brain Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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