Deep Brain Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather information on the effectiveness of the Vercise DBS System, a Deep Brain Stimulation device, for people with Parkinson's disease. Deep Brain Stimulation (DBS) sends small electrical impulses to the brain to help manage symptoms like tremors and stiffness. The trial will also examine how image-guided programming and 3D features assist in using this system. People with Parkinson's disease considering DBS treatment might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
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. It's best to consult with the trial coordinators for specific guidance.
What is the safety track record for the Vercise DBS System?
Research has shown that the Vercise Deep Brain Stimulation (DBS) System is generally well-tolerated for treating Parkinson's disease. In earlier studies, 96% of patients and 94% of doctors reported improvements after using DBS. Another study tracked patients for five years and found that DBS can be used safely over a long period. However, like any medical treatment, DBS carries some risks, including possible infection, device problems, or surgical issues. Discussing these risks with a doctor is important to understand their implications.12345
Why are researchers excited about this trial?
Researchers are excited about the Vercise DBS System because it offers a unique way to manage Parkinson's disease symptoms through deep brain stimulation. Unlike traditional Parkinson's treatments, which often rely on medications to manage dopamine levels, the Vercise DBS System directly targets the brain's electrical activity. This system allows for precise control and customization of stimulation levels, potentially leading to more consistent and effective symptom relief. Additionally, it may help reduce the side effects commonly associated with long-term medication use, offering a promising alternative for patients who have not responded well to conventional treatments.
What evidence suggests that the Vercise DBS System is effective for Parkinson's disease?
Research has shown that deep brain stimulation (DBS) with the Vercise system can greatly benefit people with Parkinson's disease. In one study, 96% of patients and 94% of doctors observed improvements after using the Vercise DBS system. Another study found that patients experienced better movement control one year after DBS, with benefits lasting up to five years. The Vercise system uses advanced technology to deliver steady brain stimulation, which has proven safe and effective. Overall, strong evidence supports the Vercise DBS system's effectiveness in treating Parkinson's disease.15678
Who Is on the Research Team?
Natalie Bloom Lyons
Principal Investigator
Boston Scientific Neuromodulation Corporation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Vercise DBS for deep brain stimulation and are evaluated using Image Guided Programming and DBS Illumina 3D features
Follow-up
Participants are monitored for improvement in disease symptoms and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Vercise DBS System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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
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.
bostonscientific.com
bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/clinical-data.htmlVercise Genus DBS System clinical data
96% of patients and 94% clinicians reported improvement following deep brain stimulation (DBS). See the full Real-World Outcomes in the USA study. Percent ...
Five-Year Outcomes from Deep Brain Stimulation of the ...
From screening, a significant improvement in motor outcomes is reported 1 year after deep brain stimulation (DBS) and sustained out to 5 years.
5-year Follow-Up of a Prospective, Double-Blind RCT (S16 ...
Long-term follow-up from the INTREPID RCT demonstrates that the use of a multiple-source, constant-current DBS system is safe and effective.
Vercise™ Deep Brain Stimulation Systems for Parkinson's ...
Appendix A provides a summary of the data supporting the clinical effectiveness of GPi stimulation for Parkinson's disease. The clinically established ...
NCT01839396 | Deep Brain Stimulation (DBS) for the ...
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of ...
summary of safety and effectiveness data (ssed)
The following is a list of known risks with the use of Deep Brain Stimulation for the treatment of Parkinson's disease. There may be risks that are unknown.
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.
Clinical Outcomes from Deep Brain Stimulation with ...
At a mean follow-up of one-year post DBS implantation, MICC stimulation alone resulted in greater than 50% improvement in UPDRS motor scores.
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