Deep Brain Stimulation for Parkinson's Disease

Overseen By Nicole Bentley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Stroke, Seizure, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores brain function during non-motor symptoms, such as depression and slower thinking, in individuals with movement disorders like Parkinson's disease and essential tremor. Researchers use deep brain stimulation (DBS), which involves placing electrodes in the brain, to study brain activity during routine surgery. Participants include those diagnosed with Parkinson's disease or essential tremor who experience movement issues unresponsive to medication and qualify for surgery. As an unphased trial, this study provides participants a unique chance to contribute to groundbreaking research that could enhance understanding and treatment of non-motor symptoms in movement disorders.

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 deep brain stimulation is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is generally well-tolerated for people with Parkinson's disease. In a long-term study, patients who underwent DBS experienced relief from movement problems for up to five years. Although this treatment does not halt disease progression, it offers lasting benefits.

Another study found that DBS provides significant benefits in the moderate stages of Parkinson's disease, indicating it is no longer just a last-resort option. Additionally, a review of multiple studies demonstrated that DBS is both effective and safe, even when robots assist during surgery.

DBS has been used for some time and also treats other conditions, supporting its safety. However, like any medical procedure, risks and side effects can occur, so discussing these with a doctor is important. ^{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 potentially improve motor symptoms that are not fully addressed by current medications like levodopa and dopamine agonists. Unlike these standard treatments, which primarily focus on replacing or mimicking dopamine, DBS directly targets specific brain regions to modulate abnormal neural activity. This approach can provide more consistent symptom control and reduce medication requirements, which may lead to fewer side effects. Additionally, DBS is adjustable and reversible, offering a level of customization and safety that is appealing to both patients and healthcare providers.

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

Research has shown that deep brain stimulation (DBS), which participants in this trial may receive, can help treat Parkinson's disease. Studies have found that DBS can improve movement by 29% and enhance quality of life by 18% compared to the best available medications. Another study reported a 26% improvement in quality of life for patients using DBS. These benefits can reduce the need for Parkinson's medications and help manage symptoms more effectively. However, it's important to understand that while DBS can improve symptoms, it does not halt the progression of the disease. Overall, DBS offers significant benefits for people with Parkinson's disease. ^{3 6 7 8 9}

Who Is on the Research Team?

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.

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?

Group I: Treatment Experimental Treatment 1 Intervention

Parkinson's Disease Patients receiving DBS electrodes

Group II: Control Active Control 1 Intervention

Control subjects will be non-Parkinson's Disease patients with essential tremor

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

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping Go-No-Go performance within the subthalamic nucleus region. Hershey, T., Campbell, MC., Videen, TO., et al.[2022]

In a study involving 34 participants (17 with Parkinson's disease and 17 healthy controls), subthalamic nucleus deep-brain stimulation was found to increase impulsive responses in high-conflict situations, suggesting a potential risk for impulsivity in patients.

However, the same stimulation also enhanced the ability to engage inhibitory control later in the reaction process, indicating that while it may lead to more impulsive actions initially, it can improve the ability to correct those actions and select the appropriate response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus stimulation influences expression and suppression of impulsive behaviour in Parkinson's disease. Wylie, SA., Ridderinkhof, KR., Elias, WJ., et al.[2022]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep brain stimulation (DBS) in both the Subthalamic Nucleus (STN) and Globus Pallidus (GPi) significantly affects inhibitory control in Parkinson's disease patients, leading to increased impulsive errors but improved ability to suppress interference from action impulses.

The study involved 33 Parkinson's disease patients (20 with STN DBS and 13 with GPi DBS) and found that both stimulation targets produced similar effects on impulsive behavior, suggesting that both regions play a crucial role in managing action impulse control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of deep brain stimulation target on the activation and suppression of action impulses. Dietz, N., Alhourani, A., Wylie, SA., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus stimulation, dopaminergic treatment and impulsivity in Parkinson's disease. Fluchère, F., Burle, B., Vidal, F., et al.[2019]

Deep brain stimulation (DBS) is an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

Deep brain stimulation (DBS) can improve motor function and quality of life in patients with Parkinson's disease when used alongside traditional medication, particularly for those whose symptoms are not well-controlled by medication alone.

However, while DBS offers significant benefits, it also comes with a higher risk of adverse events compared to pharmacotherapy, highlighting the need to carefully consider the risks and benefits before opting for this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. Sharma, A., Szeto, K., Desilets, AR.[2012]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) effectively treats motor symptoms in Parkinson's disease by creating a mixture of firing responses in the basal ganglia output nuclei, which enhances therapeutic effects.

The study suggests that the optimal frequency for STN DBS is above 100 Hz, as this frequency leads to a significant change in response patterns, and highlights that alternative stimulation methods, like optogenetics, may not achieve the same therapeutic outcomes as electrical DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network effects of subthalamic deep brain stimulation drive a unique mixture of responses in basal ganglia output. Humphries, MD., Gurney, K.[2012]

Deep brain stimulation (DBS) for Parkinson's disease affects the brain by both exciting and inhibiting neural activity, leading to changes in brain rhythms and neurochemical levels, which can improve motor and non-motor symptoms.

Recent advancements in DBS technology have led to the development of adaptive DBS systems that can adjust stimulation based on real-time feedback from the brain, potentially enhancing treatment effectiveness for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiology of deep brain stimulation. Rosa, M., Giannicola, G., Marceglia, S., et al.[2022]

In patients with Parkinson's disease, unilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) improved reaction times to 'go' stimuli but did not enhance reaction times to 'stop' stimuli, indicating a complex interaction between DBS and response inhibition.

When focusing on patients with baseline stop-signal reaction times similar to healthy controls, DBS led to slower stop-signal reaction times, particularly with left-sided stimulation, suggesting that DBS may disrupt the STN's role in inhibiting responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the subthalamic nucleus in response inhibition: evidence from deep brain stimulation for Parkinson's disease. Ray, NJ., Jenkinson, N., Brittain, J., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse Visually Guided Reaching in Patients with Parkinson's Disease. Gaprielian, P., Scott, SH., Levy, R.[2022]

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This meta-analysis aims to assess the effectiveness and safety of robot-assisted deep brain stimulation (DBS) surgery for Parkinson's disease(PD).

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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 ...