Deep Brain Stimulation for Parkinson's Disease

JW
Overseen ByJoshua Wong, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new patterns of Deep Brain Stimulation (DBS) for individuals with Parkinson's disease. Researchers aim to determine if these patterns can be safely and comfortably used at home. The trial includes three different treatment groups: one uses a special biphasic waveform, another applies theta burst stimulation during sleep, and the last employs alternating frequencies in specific brain areas. Individuals who have had stable DBS therapy for at least six months and have Parkinson's confirmed by a specialist might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative DBS patterns that could improve daily life for Parkinson's patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Biphasic Deep Brain Stimulation (bDBS) is safe and generally well-tolerated. Studies have found no major differences when comparing bDBS to traditional treatments. It has been tested in patients with conditions like dystonia, and most participants have handled it well.

For Nocturnal Theta Burst Stimulation (tDBS), research has examined its effects on Parkinson's disease symptoms. Studies suggest that this type of stimulation might help improve certain functions. While the main focus has been on its effectiveness, safety data does not reveal major concerns.

Region-Specific Frequency Alternation (fDBS) is a newer method. Research is ongoing to determine the best settings for deep brain stimulation in Parkinson's patients. Although detailed safety data is still being collected, the fact that this method is being tested suggests it is reasonably safe, as earlier research phases must demonstrate safety before further testing.

The lack of serious side effects in these studies is encouraging. However, participants should discuss all potential risks with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Parkinson's Disease because they offer innovative approaches to deep brain stimulation (DBS). Unlike traditional DBS, which typically uses constant, unchanging electrical pulses, the Biphasic DBS (bDBS) arm uses a biphasic waveform to ensure charge balancing. The Nocturnal Theta Burst Stimulation (tDBS) arm aligns stimulation with the participant's sleep schedule, potentially enhancing therapeutic effects during nighttime. Lastly, the Region-Specific Frequency Alternation (fDBS) arm provides a customized frequency approach, applying high-frequency stimulation to certain brain regions and low-frequency to others, which could optimize symptom control. These methods aim to improve on current DBS strategies by offering more tailored and potentially more effective therapy options for individuals with Parkinson's Disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

This trial will compare different types of deep brain stimulation for Parkinson's disease. Research has shown that biphasic deep brain stimulation (bDBS), one of the treatments in this trial, works well and is safe for people with movement disorders like Parkinson's disease. In some studies, patients experienced noticeable improvements in their ability to move. Another treatment option in this trial, nocturnal theta burst stimulation (tDBS), enhanced overall function and quality of life for Parkinson's patients, with some experiencing long-lasting relief from symptoms. Region-specific frequency alternation (fDBS), also being tested in this trial, showed promise in addressing specific issues like tremors and stiffness, offering targeted relief. Each treatment has potential benefits, but results can vary from person to person.12567

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients with stable deep brain stimulation (DBS) therapy for at least 6 months, using the Boston Scientific Vercise Genus DBS System. Participants must be diagnosed by a neurologist specialized in movement disorders.

Inclusion Criteria

I have been on stable DBS therapy for at least 6 months.
I have a Boston Scientific Vercise Genus DBS System for my STN or GPi.
My Parkinson's diagnosis was confirmed by a specialist neurologist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants are programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation

1 day
1 visit (in-person)

Treatment Period 1

Participants use one of the two programmed settings for two weeks

2 weeks
1 visit (telemedicine)

Treatment Period 2

Participants switch to the alternate setting for the remaining two weeks

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Patterned Stimulation

Trial Overview

The study tests the safety of different patterned DBS methods (biphasic, theta burst, multi frequency, and conventional) when used at home by people with Parkinson's who have had previous DBS to specific brain areas.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Region-Specific Frequency Alternation (fDBS)Experimental Treatment2 Interventions
Group II: Nocturnal Theta Burst Stimulation (tDBS)Experimental Treatment2 Interventions
Group III: Biphasic DBS (bDBS)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

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

Citations

Square Biphasic Pulse Deep Brain Stimulation for Parkinson's ...

Our current results are consistent with previous studies that biphasic pulses were safe and well-tolerated in movement disorders, particularly ...

Bilateral adaptive deep brain stimulation is effective in ...

Results UPDRS scores were 43% (p=0.04; Cohen's d=1.62) better with aDBS than without stimulation. Motor improvement with aDBS occurred despite an average time ...

Deep Brain Stimulation for Parkinson's Disease and Other ...

There is level 3a evidence that bilateral DBS of the globus pallidus is effective in the control of symptoms of primary dystonia for at least 1 year. Conclusion.

Earlier versus later subthalamic deep brain stimulation in ...

Our findings suggest that an earlier STN-DBS treatment might result in a more precocious stabilization of motor complications, with beneficial effects.

Safety and Tolerability of Patterned Stimulation for DBS in ...

This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms ...

Double blind, nonrandomized crossover study of active ...

Biphasic DBS is a safe and well-tolerated novel paradigm for primary dystonia. Biphasic DBS may provide faster improvement of dystonia symptoms.

Double blind, nonrandomized crossover study of active ...

Biphasic DBS is a safe and well-tolerated novel paradigm for primary dystonia. •. Biphasic DBS may provide faster improvement of dystonia symptoms. •. Certain ...