2 Participants Needed

Burst-Type Deep Brain Stimulation for Parkinson's Disease

(BURST Trial)

NT
DW
Overseen ByDonald Whiting, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Deep Brain Stimulation (DBS) is generally well-tolerated, but complications can occur. Common issues include infections, lead migrations (movement of the wires), and device malfunctions, which sometimes require additional surgery to fix. Further research is needed to reduce these risks.16789

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

NT

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

I have had DBS for Parkinson's in both sides of my brain for at least 6 months.
My Parkinson's medication and DBS settings have been stable for 6 months.
Comfortable using DBS controller to turn off device prior to study visits
See 1 more

Exclusion Criteria

I cannot attend all the follow-up visits.
DBS technology other than Boston scientific Genus/Gevia
My DBS targets in the brain are not the STN.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline and Randomization

Participants undergo baseline assessments and are randomized to either burst-type or standard DBS programming

1 day
1 visit (in-person)

Treatment

Participants receive burst-type DBS programming and are evaluated at 6 and 12 months

12 months
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Burst-type DBS electrical stimulation programming
  • Standard of care DBS programming
Trial Overview The study compares burst-type DBS electrical stimulation programming—a new protocol delivering intermittent bursts of stimulation—with the standard continuous high-frequency stimulation in managing Parkinson's symptoms.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Experimental Burst-type Programming First, Then Baseline ProgrammingExperimental Treatment2 Interventions
In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.
Group II: Baseline Programming First, Then Experimental Burst-type ProgrammingExperimental Treatment2 Interventions
In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.

Burst-type DBS electrical stimulation programming is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia
🇺🇸
Approved in United States as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia
  • Obsessive-compulsive disorder
🇨🇦
Approved in Canada as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia
🇯🇵
Approved in Japan as Deep Brain Stimulation for:
  • 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

Trials
52
Recruited
13,000+

Boston Scientific Corporation

Industry 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

Findings from Research

Deep Brain Stimulation (DBS) is an established treatment for Parkinson's Disease, and standardized postoperative programming can enhance symptom relief and quality of life for patients.
An expert consensus developed by Chinese specialists aims to standardize DBS programming, which is expected to improve the overall management of patients after surgery.
Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease.Chen, S., Gao, G., Feng, T., et al.[2022]
Both 'awake' and 'asleep' deep brain stimulation (DBS) techniques for Parkinson's disease have reliable targeting accuracy for lead placement, ensuring effective treatment.
There are no significant differences in clinical outcomes, costs, or complications between the two DBS techniques, making them equally viable options for patients.
Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review.Wang, J., Ponce, FA., Tao, J., et al.[2022]
A study involving 11 subjects with Parkinson's disease and essential tremor demonstrated that nonconventional deep brain stimulation (DBS) settings, such as narrow pulse widths and square biphasic pulses, were well tolerated and could potentially improve motor outcomes compared to standard settings.
The research indicates that some nonconventional DBS settings may provide similar or even greater benefits without compromising the efficiency of the implantable pulse generators, suggesting that simple firmware upgrades could enhance DBS therapy options.
Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses.Akbar, U., Raike, RS., Hack, N., et al.[2023]

References

Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease. [2022]
Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review. [2022]
Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. [2023]
Early Experience With New Generation Deep Brain Stimulation Leads in Parkinson's Disease and Essential Tremor Patients. [2022]
The modulatory effect of adaptive deep brain stimulation on beta bursts in Parkinson's disease. [2023]
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]
How to avoid trivial mistakes during IPG replacement in patients treated with DBS for movement disorders: technical note from 13-years experience. [2015]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]
Subthalamic Nucleus Deep Brain Stimulation in a Patient with Severe Axial Symptoms and Suboptimal Levodopa Responsive Parkinson's Disease. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Survey of U.S. neurologists' attitudes towards deep brain stimulation for Parkinson's disease. [2022]
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