Deep Brain Stimulation for Parkinson's Disease

Overseen By Julia Choi, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Neurological surgery, Atypical parkinsonism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep brain stimulation (DBS) affects walking in people with Parkinson's disease. Researchers will study walking patterns using a special treadmill that changes speed, comparing results when the DBS device is on and off. The trial seeks participants diagnosed with Parkinson's disease who have had stable DBS for at least six months and can walk unaided. As an unphased trial, it offers participants the chance to contribute to understanding DBS's impact on mobility in Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires participants to be off-medication during the study, which means you will need to stop taking your current Parkinson's medications while participating.

What prior data suggests that Deep Brain Stimulation is safe for Parkinson's Disease?

Research has shown that deep brain stimulation (DBS) is generally safe for treating Parkinson's disease. Studies indicate that DBS can improve movement, mood, and overall quality of life for people with Parkinson's. Most patients tolerate the treatment well.

Research on long-term effects found that DBS is linked to good survival rates over many years. However, like any medical procedure, risks exist. Some patients may experience complications, but these are usually rare.

Another study suggested that DBS works best during the moderate stages of Parkinson's. While there can be some risks, many people tolerate DBS well and see significant improvements in their daily lives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Brain Stimulation (DBS) for Parkinson's disease because it offers a unique way to manage symptoms by directly targeting brain activity. Unlike traditional treatments like medication that focuses on balancing brain chemicals, DBS involves implanting electrodes in specific brain regions and using electrical impulses to regulate abnormal activity. This method can be adjusted and personalized for each patient, providing a level of control that standard drugs do not offer. Moreover, DBS has the potential to reduce the need for medication, minimizing their side effects and improving the quality of life for patients with Parkinson's.

What evidence suggests that Deep Brain Stimulation is effective for Parkinson's Disease?

Research has shown that Deep Brain Stimulation (DBS) can significantly benefit people with Parkinson's Disease. One study found that patients' movement abilities improved by 29% with DBS compared to medication alone. Another study discovered that DBS increased quality of life by 26%, a notable improvement over the slight decline seen in those only on medication. DBS also allows patients to reduce medication intake, which can lessen side effects. In this trial, participants will experience different DBS settings; some will have DBS turned on, while others will have it turned off, to further evaluate its effectiveness in managing symptoms and enhancing daily life for those with Parkinson's Disease. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who have been diagnosed by experts, have had Deep Brain Stimulation (DBS) for at least 6 months, can walk without help or aids, and do not have dementia. It's not suitable for those outside these criteria.

Inclusion Criteria

I have been diagnosed with Parkinson's disease by a specialist.

My DBS settings have been stable and optimized for at least 6 months.

I do not have dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants perform baseline walking with a 1:1 speed ratio on a split-belt treadmill

1 hour

Split-belt Adaptation

Participants undergo split-belt adaptation with a 2:1 speed ratio under DBS ON and DBS OFF conditions

1 hour

Post-adaptation

Participants perform post-adaptation walking with a 1:1 speed ratio to assess after-effects

1 hour

Follow-up

Participants are monitored for safety and effectiveness after the adaptation phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation (DBS)

Trial Overview

The study tests how walking adapts when the treadmill speeds are uneven (split-belt), comparing patients' performance with their DBS turned on and off while they're not on medication.

How Is the Trial Designed?

Group I: DBS OFF Active Control 1 Intervention

DBS will be turned off

Group II: DBS ON Active Control 1 Intervention

DBS will be turned on

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

NATL INST OF HLTH NIA

Collaborator

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ...

Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3843969/

Deep brain stimulation for the treatment of Parkinson's ...

Off medication motor function (29%) and measures of quality of life (18%) were also improved for DBS compared with best medical therapy, but there was no ...

3.

ufhealth.org

ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

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

For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

4.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2838886

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.

5.

ohsu.edu

ohsu.edu/brain-institute/dbs-outcomes

DBS Outcomes | Brain Institute

Improved quality of life: The same study found a 26% improvement in quality-of-life scores among DBS patients, compared to a 1% decline in patients taking ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12439180/

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.

journals.plos.org

journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004670

Deep brain stimulation surgical timing, outcomes, and ...

DBS significantly improved motor, mood, and quality-of-life outcomes across all PD durations, with the most substantial benefits observed in mid-duration (5–10 ...

8.

frontiersin.org

frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2023.1258190/full

Deep brain stimulation in PD: risk of complications ...

However, while DBS has been shown to be a safe and efficacious treatment for PD, even a low rate of complications may present a significant ...

9.

thejns.org

thejns.org/view/journals/j-neurosurg/132/1/article-p205.xml

Long-term outcomes following deep brain stimulation for ...

DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, it provides durable ...