140 Participants Needed

Deep Brain Stimulation for Parkinson's Disease

NB
Overseen ByNicole Bentley, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate the brain activity associated with non-motor symptoms of movement disorders, including Parkinson's disease and essential tremor. These movement disorders commonly have significant non-motor features also, including depression, cognitive impairment, decreased attention, and slower processing speeds. The investigators are interested in the brain activity associated with these symptoms, and perform recordings of the surface of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

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.

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections, lead migrations (movement of the wires), and device malfunctions. Serious complications like permanent neurological problems occur in 4-6% of cases, and over 25% of patients may experience some kind of complication.12345

How does deep brain stimulation differ from other treatments for Parkinson's disease?

Deep brain stimulation (DBS) for Parkinson's disease is unique because it involves implanting electrodes in the brain to deliver electrical impulses, specifically targeting the subthalamic nucleus. This treatment can improve motor symptoms by altering brain activity, unlike medications that primarily increase dopamine levels. DBS can also be adjusted to optimize both motor and cognitive functions, offering a personalized approach to managing symptoms.678910

What data supports the effectiveness of the treatment Deep Brain Stimulation for Parkinson's Disease?

Research shows that Deep Brain Stimulation (DBS) of the subthalamic nucleus can improve motor symptoms in Parkinson's disease and also affects cognitive functions like response inhibition. While DBS can increase impulsive responses, it also enhances the ability to control these impulses, suggesting a complex role in managing both motor and cognitive symptoms.67111213

Who Is on the Research Team?

NB

Nicole Bentley, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's disease or Essential Tremor who are eligible for deep brain stimulation (DBS) surgery. Candidates must be willing to participate in the study activities and have been reviewed by a multi-disciplinary team. People cannot join if they can't fully consent, aren't surgical candidates due to other health issues or pregnancy, haven't tried medical management adequately, or DBS isn't indicated for their condition.

Inclusion Criteria

Willingness to participate in the paradigms described in the protocol
A team of doctors agrees I am a candidate for DBS surgery.
I have been diagnosed with Parkinson's disease or Essential Tremor.

Exclusion Criteria

I cannot take part in study activities.
I cannot have surgery because of other health issues or because I am pregnant.
Deep Brain Stimulation surgery is not recommended for my condition.
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 routine deep brain stimulation (DBS) surgery with intraoperative recordings and stimulation testing

1 day
1 visit (in-person)

Neural Electrophysiology Study

Participants perform various motor and cognitive tasks while brain activity is recorded from DBS and subdural strip electrodes

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Response Inhibition and Deep Brain Stimulation
Trial Overview The study investigates brain activity related to non-motor symptoms like depression and cognitive impairment in movement disorders. It involves additional brain surface recordings during routine DBS surgery to understand these symptoms better.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

In a study involving 10 individuals with Parkinson's disease, deep brain stimulation of the ventral subthalamic nucleus specifically improved cognitive response inhibition, as evidenced by changes in performance on a Go-No-Go task, while dorsal stimulation primarily affected motor symptoms.
Both dorsal and ventral stimulation improved motor symptoms, but only ventral stimulation led to significant changes in cognitive performance, indicating that different regions of the subthalamic nucleus play distinct roles in motor control and cognitive functions.
Mapping Go-No-Go performance within the subthalamic nucleus region.Hershey, T., Campbell, MC., Videen, TO., et al.[2022]
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) in Parkinson's disease patients impairs their ability to suppress incorrect muscle impulses, leading to more impulsive actions, as shown by electromyographic (EMG) analysis during conflict reaction time tasks with 16 participants.
Dopaminergic medication affects the suppression of these impulsive actions but does not alter the negative impact of STN DBS on action control, indicating that DBS weakens the ability to control erroneous impulses regardless of medication status.
Subthalamic nucleus stimulation, dopaminergic treatment and impulsivity in Parkinson's disease.Fluchรจre, F., Burle, B., Vidal, F., et al.[2019]
In a study involving 55 healthy controls and 33 Parkinson's disease (PD) patients (26 on dopamine replacement therapy and 7 on deep brain stimulation), the reverse visually guided reaching (RVGR) task revealed that while treatments improved motor performance, they also led to increased direction errors, indicating a reduction in inhibitory control.
The RVGR task effectively measures the balance between motor function improvement and inhibitory control deficits, suggesting it could be a useful tool for screening preoperative cognitive deficits and optimizing deep brain stimulation settings for better therapeutic outcomes.
Reverse Visually Guided Reaching in Patients with Parkinson's Disease.Gaprielian, P., Scott, SH., Levy, R.[2022]

Citations

Mapping Go-No-Go performance within the subthalamic nucleus region. [2022]
Subthalamic nucleus stimulation, dopaminergic treatment and impulsivity in Parkinson's disease. [2019]
Reverse Visually Guided Reaching in Patients with Parkinson's Disease. [2022]
The role of the subthalamic nucleus in response inhibition: evidence from deep brain stimulation for Parkinson's disease. [2021]
Subthalamic nucleus stimulation influences expression and suppression of impulsive behaviour in Parkinson's disease. [2022]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Safety considerations for deep brain stimulation: review and analysis. [2007]
Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. [2008]
Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. [2012]
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]
Network effects of subthalamic deep brain stimulation drive a unique mixture of responses in basal ganglia output. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Neurophysiology of deep brain stimulation. [2022]
Effects of deep brain stimulation target on the activation and suppression of action impulses. [2023]
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