Illumina 3D Deep Brain Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help individuals with Parkinson's disease manage motor symptoms, such as walking and finger movements, using an automated deep brain stimulation (DBS) system called Illumina 3D. Researchers aim to determine if this system can improve symptoms more effectively than standard DBS settings. Participants will experience different DBS settings during the trial but will return to their usual settings afterward. This trial is suitable for those who have recently had DBS implanted and are ready for initial activation. The trial involves short-term testing, requiring no long-term commitment. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options for Parkinson's disease.
Will I have to stop taking my current medications?
The trial may require you to stop taking your current medications during research visits, as participants must be willing to withdraw from their clinical medication regimen if necessary.
What prior data suggests that this automated deep brain stimulation algorithm is safe for Parkinson's disease patients?
Studies have shown that deep brain stimulation (DBS) is generally well-tolerated by people with Parkinson's disease. Research indicates that DBS effectively improves motor symptoms, addressing the movement and control issues often experienced by those with Parkinson's. Illumina 3D, a new automated DBS method, is currently undergoing tests for safety and effectiveness.
Previous findings suggest that DBS, including the Illumina 3D method, can be safely used in patients. Side effects are rare but may include infection, bleeding, or device-related issues, typically linked to the surgery rather than the stimulation itself. In trials, patients using DBS have not shown significant safety concerns specific to the Illumina 3D method.
The trial under consideration involves short-term testing, which helps reduce risks. After testing, participants return to their usual environments, adding an extra layer of safety by preventing long-term exposure to any untested conditions.12345Why are researchers excited about this trial?
Researchers are excited about Illumina 3D Deep Brain Stimulation for Parkinson's Disease because it offers a new approach to managing symptoms. Unlike traditional deep brain stimulation, which uses a consistent amplitude, Illumina 3D allows for adjustments in amplitude, providing more personalized treatment options. This flexibility could potentially lead to more effective symptom control and reduce side effects. By fine-tuning the stimulation levels, this method aims to optimize patient outcomes, making it a promising development in Parkinson's care.
What evidence suggests that Illumina 3D Deep Brain Stimulation is effective for motor symptoms in Parkinson's disease?
Research has shown that deep brain stimulation (DBS) helps manage movement problems in people with Parkinson's disease, improving movement and reducing shaking. In this trial, participants will experience different DBS conditions, including the Illumina 3D Deep Brain Stimulation. This new tool from Boston Scientific automatically adjusts DBS settings to enhance these benefits. Studies have found that DBS leads to improved results when used with advanced programming like Illumina 3D. This technology uses images to customize treatment for each person, potentially improving their quality of life.23456
Who Is on the Research Team?
Helen Bronte-Stewart, MD, MSE
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for individuals with Parkinson's Disease who have recently had Deep Brain Stimulation (DBS) implants and are about to have them activated. Participants should be able to perform motor tasks like walking and finger tapping, and willing to answer questionnaires during a short 1-2 day study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are tested on different DBS settings determined by Illumina 3D across various motor tasks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Illumina 3D Deep Brain Stimulation
Trial Overview
The trial tests an automated DBS algorithm called Illumina 3D by Boston Scientific, aiming to improve motor symptoms in Parkinson's patients. It compares different DBS settings including reduced amplitude, higher amplitude, standard care, and sham control against the new algorithm.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants start with a sham condition (baseline) for approximately 45 minutes. Participants then receive the following four deep brain stimulation conditions in a randomized order for approximately 45 minutes each delivered by the Boston Scientific Vercise Genus neurostimulator. Neither the participants nor the assessor will be aware of what condition they receive. Before starting the condition, there will be a wash in for approximately 15 minutes. Participants will then perform tasks and questionnaires for approximately 30 minutes on each condition. The four conditions are: 1. Standard of Care Deep Brain Stimulation 2. Illumina 3D Deep Brain Stimulation 3. Illumina 3D Deep Brain Stimulation Reduced Amplitude 4. Illumina 3D Deep Brain Stimulation Higher Amplitude
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Boston Scientific Corporation
Industry 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
Neuroimaging in deep brain stimulation: Bridging technical ...
Subthalamic span of β oscillations predicts deep brain stimulation efficacy for patients with parkinson's disease. Brain, 133 (7) (2010), pp. 2007-2021.
Illumina 3D Deep Brain Stimulation for Parkinson's Disease
This trial is for individuals with Parkinson's Disease who have recently had Deep Brain Stimulation (DBS) implants and are about to have them activated.
Patient, target, device, and program selection for DBS in ...
DBS has demonstrated consistent efficacy in managing many aspects of PD in at least eight high-quality randomized controlled DBS trials ...
4.
bostonscientific.com
bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/image-guided-programming.htmlImage Guided Programming
Illumina 3D Technology enables easy and efficient deep brain ... deep brain stimulation improves clinical outcomes in patients with Parkinson's disease.
Study Details | NCT02071134 | Registry of Deep Brain ...
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system ...
Automated Image-Guided Programming of Deep Brain ...
The primary outcome is the difference in QDG Mobility Score from the OFF DBS condition (baseline) to Illumina 3D DBS. The Illumina 3D DBS ...
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