Brain Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how deep brain stimulation (DBS), which uses electrical impulses to influence brain activity, can be tailored to help people with Parkinson's Disease. Researchers will test various methods to stimulate specific brain areas, seeking the most effective approach for each participant. The trial seeks individuals who have had Parkinson's for 4 or more years, have chosen to undergo DBS surgery, and experience severe motor symptoms like tremors or stiffness despite medication. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research that could personalize DBS treatment for future patients.
Will I have to stop taking my current medications?
The trial requires that participants have stable doses of Parkinson's disease medications for at least 28 days before starting the study. This means you should not change your current medications leading up to the trial.
What prior data suggests that this device is safe for use in Parkinson's Disease?
Research shows that deep brain stimulation (DBS) is generally well-tolerated for treating Parkinson's disease. Studies have demonstrated that DBS can be safe over long periods. Specifically, one study found that using DBS in the subthalamic nucleus has been safely used for more than five years in treating Parkinson's. Patients usually experience fewer side effects compared to other treatments.
However, like any procedure, DBS has risks. Some people might experience side effects such as speech problems or mood changes, but adjusting the device settings can often manage these issues.
DBS is already a well-known and common treatment for Parkinson's, which gives confidence in its safety for many patients. The Neuromodulation eXperiment Testbed system (NEXT) uses similar principles to DBS, suggesting it is likely to be similarly safe based on past experiences with DBS.12345Why are researchers excited about this trial?
Researchers are excited about the Neuromodulation eXperiment Testbed system (NEXT) stimulation for Parkinson's Disease because it offers a new approach compared to traditional treatments like medication and deep brain stimulation. Unlike standard options that often focus on medication adjustments or consistent stimulation in one area, NEXT stimulation explores the effects of targeting different brain regions, such as the subthalamic nucleus (STN) and the globus pallidus internus (GPi), either individually or in combination. This tailored approach could lead to more personalized and effective management of symptoms, potentially reducing side effects and enhancing quality of life for patients. By testing multiple configurations over time, researchers hope to uncover the most beneficial stimulation patterns for individuals with Parkinson's.
What evidence suggests that this device is effective for Parkinson's Disease?
Research has shown that deep brain stimulation (DBS) is a proven treatment for people with advanced Parkinson's disease. Studies have found that it reduces symptoms like tremors and improves quality of life. One study found that DBS targeting the subthalamic nucleus had positive results over five years, demonstrating its long-term benefits. Another study suggested that DBS is more effective than other treatments for advanced stages of the disease. In this trial, the Neuromodulation eXperiment Testbed system (NEXT) will stimulate different brain areas, including the subthalamic nucleus (STN) and the globus pallidus internus (GPi), either alone or in combination, across different treatment arms. This approach aims to improve DBS by tailoring it to each person's unique brain activity, potentially increasing its effectiveness.12456
Who Is on the Research Team?
Harrison Walker, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced Parkinson's Disease (PD), showing at least two of three main PD symptoms, and having had the disease for four years or more. Candidates must be planning to undergo awake DBS surgery where either STN or GPi is the target, have a mostly normal brain MRI, can cooperate during surgery/post-op evaluations, and have insurance covering DBS as routine care. They should also have refractory motor symptoms despite treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Assessment
Standard of care DBS surgery and initial assessment of brain signals using an external stimulation/recording system
Treatment Arm 1
Stimulation from either STN alone, GPi alone, or a combination of both STN and GPi
Treatment Arm 2
Stimulation from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arm 1
Treatment Arm 3
Stimulation from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arms 1 and 2
Open-label Extension
Unblinded open-label encounter utilizing optimized stimulation parameters
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neuromodulation eXperiment Testbed system (NEXT) stimulation
Neuromodulation eXperiment Testbed system (NEXT) stimulation is already approved in United States, European Union for the following indications:
- Parkinson's disease
- Essential tremor
- Epilepsy
- Parkinson's disease
- Essential tremor
- Dystonia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator