Burst-Type Deep Brain Stimulation for Parkinson's Disease
(BURST Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it requires that your Parkinson's disease medications have been stable for at least 6 months before joining.
What data supports the effectiveness of the treatment Burst-Type Deep Brain Stimulation for Parkinson's Disease?
Research suggests that nonconventional deep brain stimulation (DBS) patterns, like burst-type stimulation, may improve treatment for movement disorders such as Parkinson's Disease. Adaptive DBS, which adjusts stimulation based on brain activity, has shown potential to be more effective than traditional DBS by targeting specific brain activity patterns associated with symptoms.12345
Is Burst-Type Deep Brain Stimulation generally safe for humans?
How is Burst-Type Deep Brain Stimulation different from other treatments for Parkinson's Disease?
Burst-Type Deep Brain Stimulation (DBS) is unique because it uses a specific pattern of electrical stimulation that may offer more precise control over symptoms compared to standard DBS. This approach can potentially improve energy efficiency and symptom management by delivering stimulation in bursts rather than continuously.1241011
What is the purpose of this trial?
This is a study to evaluate Deep brain stimulation (DBS) burst-type electrical stimulation programming verses standard DBS programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. Burst type DBS may improve the efficacy and durability of DBS pulse generator.
Research Team
Nestor Tomycz
Principal Investigator
Allegheny Health Network AGH Department of Neuroscience
Eligibility Criteria
This trial is for Parkinson's Disease patients who've had bilateral DBS-STN implants for at least 6 months, can use a DBS controller, and have stable medication and DBS settings. It excludes those with non-Boston scientific Genus/Gevia DBS tech, cognitive decline, or inability to complete follow-ups.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Randomization
Participants undergo baseline assessments and are randomized to either burst-type or standard DBS programming
Treatment
Participants receive burst-type DBS programming and are evaluated at 6 and 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Burst-type DBS electrical stimulation programming
- Standard of care DBS programming
Burst-type DBS electrical stimulation programming is already approved in European Union, United States, Canada, Japan for the following indications:
- Parkinson's disease
- Essential tremor
- Dystonia
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Parkinson's disease
- Essential tremor
- Dystonia
- Parkinson's disease
- Essential tremor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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