100 Participants Needed

Deep Brain Stimulation for Parkinson's Disease

YM
Overseen ByYuhan Mou, Ph.D.
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 how deep brain stimulation (DBS), a surgery that helps control Parkinson's disease symptoms, affects voice, swallowing, and coughing. It compares two brain targets for DBS: the subthalamic nucleus (STN) and the globus pallidus internal segment (GPi), to determine which is better for these functions. Suitable participants have Parkinson's disease, mild or moderate issues with voice or swallowing, and have been approved for DBS surgery. This research could guide doctors in selecting the best DBS target to improve patients' quality of life. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for future 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.

What prior data suggests that deep brain stimulation is safe for people with Parkinson's disease?

Research shows that deep brain stimulation (DBS) surgery is generally safe for treating Parkinson's disease. When DBS targets the subthalamic nucleus (STN), studies have found it can greatly improve movement, with long-lasting benefits. Over five years, patients experienced improvements in daily activities without major safety issues.

Similarly, DBS targeting the globus pallidus internal segment (GPi) is also safe and effective for managing movement problems in advanced Parkinson's disease. The safety of both STN and GPi DBS is similar, with consistent results over time. While all surgeries carry risks, DBS remains a well-established method for helping people with Parkinson's disease.12345

Why are researchers excited about this trial?

Researchers are excited about deep brain stimulation (DBS) for Parkinson's disease because it offers a more targeted approach compared to standard treatments like medication therapy with Levodopa or other dopamine agonists. Unlike these medications, which can have widespread effects throughout the body, DBS specifically targets areas in the brain responsible for motor control. The two DBS methods being explored—subthalamic nucleus (STN) and globus pallidus internus (GPi) stimulation—allow for precision in reducing symptoms like tremors and stiffness. This precision can lead to more significant improvements in quality of life and fewer side effects, making it a promising option for those with Parkinson's.

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

Research has shown that deep brain stimulation (DBS) effectively addresses movement problems in people with Parkinson's disease. In this trial, participants will receive DBS targeting either the subthalamic nucleus (STN) or the globus pallidus internal segment (GPi). Studies have found that DBS targeting the STN significantly improves movement and daily activities, with benefits lasting five years or more. Similarly, DBS aimed at the GPi reduces movement issues and medication-related problems. Both STN and GPi targets are safe and effective for controlling symptoms like tremors and involuntary movements. Overall, evidence supports that DBS at either target improves the quality of life for people with Parkinson's disease.14678

Who Is on the Research Team?

KH

Karen Hegland, Ph.D.

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease considering Deep Brain Stimulation (DBS) surgery. It aims to understand how different DBS targets affect speech and swallowing functions. Participants should be eligible for the surgery but have not yet undergone it.

Inclusion Criteria

I have mild to moderate issues with my voice or swallowing.
I was diagnosed with Parkinson's disease by a specialist, not caused by genetics.
My Parkinson's disease is between stages I and IV.
See 1 more

Exclusion Criteria

History of structural, functional, or neurologic voice disorder unrelated to PD
I have a history of cancer in my head, neck, or lungs.
I have a long-term cough that hasn't improved with treatment.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Evaluation

Participants undergo baseline assessments including laryngeal function, voice, cough, and swallowing evaluations prior to DBS surgery

6-12 months
1 visit (in-person)

Post-Surgery Follow-up

Participants are assessed for changes in laryngeal function, voice, cough, and swallowing after DBS surgery with stimulators on and off

6-12 months
3 visits (in-person)

Long-term Follow-up

Participants are monitored for any long-term changes in motor and non-motor symptoms related to DBS

6-12 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Deep brain stimulation surgery - GPi
  • Deep Brain Stimulation Surgery - STN
Trial Overview The study tests the impact of DBS on voice, swallow, and cough function in Parkinson's patients. Two common surgical targets, STN and GPi, are compared pre- and post-surgery to see if they influence these laryngeal functions differently.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: STN DBSExperimental Treatment1 Intervention
Group II: GPi DBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

Globus Pallidus Internus (GPi) Deep Brain Stimulation for ...DBS of the GPi (GPi DBS) is an established, safe and effective method for addressing many of the motor symptoms associated with advanced PD.
Deep-Brain Stimulation of the Subthalamic Nucleus or ...Bilateral stimulation of the subthalamic nucleus or pars interna of the globus pallidus is associated with significant improvement in motor function in patients ...
Guidelines on Subthalamic Nucleus and Globus Pallidus ...Deep brain stimulation (DBS) is an established therapy for improving motor symptoms and levodopa-induced dyskinesias in patients with Parkinson's disease (PD).
Comparison of the Long-Term Efficacy of Targeting ...The results indicated that the STN stimulation is effective at reducing motor symptoms during off-medication treatment for up to 15 years and ...
Medication versus globus pallidus internus deep brain ...Notably, GPi DBS significantly improved speed and acceleration parameters compared to medication. Our study results indicate that GPi DBS and ...
The safety profile of subthalamic nucleus and globus ...This study investigates the surgical and psychological complications associated with DBS surgery for movement disorders, aiming to quantify patient risk.
Brain StimulationDeep brain stimulation (DBS) of the globus pallidus internus (GPi) has been shown to be a safe and effective alternative therapy for ameliorating medically ...
Globus Pallidus vs Subthalamic Nucleus Deep Brain ...CONCLUSIONS: The efficacy and the safety of DBS is comparable by target and stable over time. GPi DBS appears to significantly improve ...
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