75 Participants Needed

Neural Stimulation for Parkinson's Disease

SB
IL
Overseen ByIsabel Long, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
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 brain activity in people with Parkinson's disease, focusing on behaviors like risk-taking and reward-seeking. Researchers use neural stimulation, which involves electrical impulses to stimulate specific brain areas, and recordings during scheduled deep brain stimulation surgery to better understand these nonmotor symptoms. Participants should plan to have this surgery at Vanderbilt University Medical Center and be able to participate in testing during the procedure. This study targets individuals diagnosed with Parkinson's disease or another movement disorder who can follow instructions during surgery. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on Parkinson's disease.

Do I need to stop my current medications for the trial?

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 neural stimulation and neurophysiology recordings are safe for Parkinson's disease patients?

Studies have shown that deep brain stimulation (DBS), a type of brain treatment, is generally safe for people with Parkinson's disease. Research indicates that DBS can reduce the need for Parkinson's medications, potentially lowering the side effects from those drugs. One study focused on older patients found that DBS is both safe and effective. Another study reported that 51% of people who received DBS were still alive after 10 years, suggesting it offers lasting benefits. Overall, DBS appears to be well-tolerated, even over a long period.12345

Why are researchers excited about this trial?

Neural stimulation is unique because it directly targets the brain's electrical activity to help manage Parkinson's disease symptoms. Unlike traditional treatments like levodopa or dopamine agonists, which work by increasing dopamine levels in the brain, neural stimulation influences the brain's neural circuits directly and non-invasively. Researchers are excited because this method could offer more precise symptom control without the side effects commonly associated with medications. Plus, neurophysiology recordings during the process could provide valuable insights into the brain's functioning, paving the way for even more personalized and effective treatments in the future.

What evidence suggests that neural stimulation is effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) can improve movement problems in people with Parkinson's disease. One study found that participants experienced significantly better movement abilities one year after receiving DBS, with benefits lasting up to five years. Another study found that DBS can reduce the need for Parkinson's medication and enhance quality of life. DBS targeting the subthalamic nucleus is a well-established treatment for advanced Parkinson's disease, helping improve daily experiences. Although DBS does not halt disease progression, it effectively manages symptoms. Participants in this trial will receive neural recordings and stimulation, which may offer similar benefits.26789

Who Is on the Research Team?

SB

Sarah Bick

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 40 or older with Parkinson's disease who are scheduled for deep brain stimulation surgery at Vanderbilt University Medical Center. Participants must be able to undergo testing during the operation and speak English.

Inclusion Criteria

Planned clinical electrode trajectory that contacts caudate
I can undergo tests during surgery.
English speaking
See 3 more

Exclusion Criteria

I am under 40 years old.
I am unable to follow instructions or directions during surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Deep Brain Stimulation Surgery

Neural recordings from corticostriatal structures are performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease

3-4 hours

Follow-up

Participants are monitored for safety and effectiveness after the surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Neural Stimulation
  • Neurophysiology Recordings

Trial Overview

The study aims to understand reward signaling in Parkinson's by recording brain activity from specific areas during neural stimulation provided in deep brain stimulation surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Neural recordings and stimulationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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