30 Participants Needed

DBS Programming 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 explores new ways to program deep brain stimulation (DBS) for people with Parkinson's disease, focusing on improving motor symptoms. Researchers compare three programming methods to identify the best one: the usual clinician-based method, a beta power-based method, and a new broad-band approach. People with Parkinson's who use a specific DBS device and can attend their initial programming sessions qualify as good candidates for this trial. The goal is to make DBS more effective and efficient for patients. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance DBS programming and improve quality of life.

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 study team or your doctor.

What prior data suggests that this DBS programming method is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease. One study found that using DBS for over five years safely helped manage Parkinson's symptoms. Another study demonstrated a 21.9% improvement in motor skills for patients using DBS.

Researchers have tested new ways to program DBS, such as using smartwatches to measure tremors, for safety. These methods aim to enhance DBS effectiveness without increasing risk. Overall, DBS is a trusted treatment for Parkinson's and is usually well-tolerated. However, discussing any concerns with a healthcare team is always important.1234

Why are researchers excited about this trial?

Researchers are excited about the DBS Programming trial for Parkinson's Disease because it explores different approaches to optimizing deep brain stimulation (DBS) therapy. Unlike the traditional clinician-based method, which relies on a doctor's expertise to fine-tune the DBS settings, the trial also investigates a maximum beta power-based approach that adjusts settings based on specific brain wave patterns. Additionally, the broad-band technique offers an experimental method that potentially covers a wider range of brain activity. By comparing these methods, researchers hope to discover which one provides the most effective symptom relief and improves quality of life for patients with Parkinson's Disease.

What evidence suggests that this trial's DBS programming methods could be effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) can significantly enhance movement problems in people with Parkinson's disease. One study reported a 53% improvement in patients' movement abilities after two years of DBS use. Another study found a 21.9% improvement in movement and an overall boost in well-being with a self-adjusting type of DBS. DBS is most effective in the middle stages of Parkinson's, offering long-lasting benefits. This trial will compare different DBS programming methods, including a traditional clinician-based approach and new data-driven techniques, such as maximum beta power-based and broad-band programming, to identify which method provides the most improvement.23567

Who Is on the Research Team?

JW

Joshua Wong, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals aged 21-89 with idiopathic Parkinson's Disease who meet specific clinical criteria. Participants must have a DBS implant (Percept device by Medtronic) to treat motor symptoms and be able to consent to the study. They should be available for initial programming sessions.

Inclusion Criteria

I am between 21 and 89 years old.
I can understand and agree to the study's details.
I have been diagnosed with Parkinson's disease according to the Movement Disorder Society.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo DBS programming using clinician-based and electrophysiology-based methods

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DBS Programming

Trial Overview

The study tests new ways of setting up deep brain stimulation (DBS) using brain signals, comparing broad-band and beta power-based programming against standard clinician methods in Parkinson's patients, aiming to find more efficient settings.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Broad-bandExperimental Treatment1 Intervention
Group II: Clinician-basedActive Control1 Intervention
Group III: Maximum beta power-basedActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

DBS Outcomes | Brain Institute

For Parkinson's patients · Improved movement: One study found that patient motor scores improved 53% after two years with DBS, compared to improving 4% among ...

UF-led study shows deep brain stimulation benefits for ...

“DBS used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

Chronic adaptive deep brain stimulation for Parkinson's ...

On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

Image-guided programming deep brain stimulation ...

The MDS-UPDRS III motor scale showed a 21.9% improvement and the DBS-IS global score improved by 41.5%. IGP optimizes STN-DBS therapy for PD ...

Sustained Benefits of Deep Brain Stimulation of the ...

This 5-year data demonstrates that STN-DBS provides significant and sustained improvements in motor function and activities of daily living.

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.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35921806/

Automated deep brain stimulation programming with safety ...

In this study, we describe and evaluate an automated, closed-loop, and patient-specific framework for DBS programming that measures tremor using a smartwatch.