15 Participants Needed

Brain Electrode for Parkinson's Disease

PD
Overseen ByPamela David Gerecht, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
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 tests a new brain electrode to help people with Parkinson's disease who do not respond well to medication. The study involves temporarily placing a special probe (large-scale intracranial electrode) in the brain during a planned surgery to manage symptoms. It targets individuals with Parkinson's who find medications insufficient and are planning to undergo awake brain surgery. Participants must be comfortable being awake during the procedure and able to understand instructions in English. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves deep brain stimulation for those whose Parkinson's disease is not controlled by medication, it's possible that some medication adjustments might be necessary. Please consult with the study team for specific guidance.

What prior data suggests that this brain electrode is safe for use in humans?

Research shows that deep brain stimulation (DBS) is generally safe when performed by experienced medical centers. Studies have found that DBS can greatly improve symptoms, particularly for conditions like Parkinson's disease. For example, one study reported a significant improvement in movement abilities by 49–71% after DBS treatment.

While the temporary use of large electrodes in the brain remains under study, current research on DBS suggests it is well-tolerated. Most patients do not experience serious side effects, though some may encounter temporary issues after electrode placement, such as mild discomfort or minor bleeding near the insertion site.

Overall, evidence supports that DBS and similar treatments, when carefully monitored, are safe for many patients.12345

Why are researchers excited about this trial?

Most treatments for Parkinson's disease, like levodopa or deep brain stimulation, aim to manage symptoms by enhancing dopamine levels or interrupting abnormal brain signals. However, the temporary implantation of large-scale intracranial electrodes offers something different. This method directly targets and modulates brain activity on a larger scale than current approaches, potentially providing more precise control over symptoms. Researchers are excited because this could lead to improved movement control and a better quality of life for patients, with fewer side effects compared to long-term pharmaceutical treatments.

What evidence suggests that this brain electrode is effective for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) greatly benefits people with Parkinson's disease. Studies have found that DBS improves movement symptoms, reduces the need for medication, and enhances overall quality of life. This technique involves placing small electrodes in the brain to stimulate certain areas, aiding in better movement control. Some research also suggests that electrode placement might affect impulsivity and memory, although the primary goal is to improve movement. In this trial, participants will receive a temporary implantation of large-scale intracranial electrodes, which researchers are studying for its potential effectiveness in managing Parkinson's disease symptoms.23678

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are already scheduled for awake Deep Brain Stimulation (DBS) surgery. Specific eligibility criteria details are not provided, but typically participants must meet certain health standards and give informed consent.

Inclusion Criteria

Able to participate and comply with tasks adequately, including instructions provided in English
I am cleared by a neurosurgeon for deep brain stimulation surgery.
Able to provide informed consent
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Recording

Neuropixels probes are inserted and removed during awake Deep Brain Stimulation (DBS) surgery to record neuronal activity

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgery and recording

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brain electrode
  • Temporary implantation of large-scale intracranial electrode
Trial Overview The study tests the use of Neuropixels probes in human brains during awake DBS surgery. The probe is temporarily inserted to record brain activity related to executive functions and then removed.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ImplantedExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Published Research Related to This Trial

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.
Safety considerations for deep brain stimulation: review and analysis.Grill, WM.[2007]
In a study of 69 patients with advanced Parkinson's disease who underwent deep brain stimulation (DBS), 53% of those with subthalamic nucleus (STN) stimulation reported ongoing adverse events (AEs) four years post-surgery, compared to 35% in the internal globus pallidus (GPi) group.
Most AEs were not severe and affected cognitive, psychiatric, and motor functions, with a notable correlation between the presence of AEs and longer disease duration and pre-existing gait and psychiatric issues in STN DBS patients.
Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years.Hariz, MI., Rehncrona, S., Quinn, NP., et al.[2008]
Deep brain stimulation (DBS) is a reversible and adjustable treatment for movement disorders like essential tremor and Parkinson's disease, with a low complication risk of ≤ 5% at experienced centers.
Future advancements in DBS technology include directional brain electrodes and 'closed loop' systems that can adapt stimulation based on real-time brain activity, potentially improving treatment outcomes.
Deep brain stimulation for movement disorders.Larson, PS.[2021]

Citations

Insertional effect following electrode implantationIn summary, STN electrode insertion was found to play a role on impulsivity and memory disturbance, while it was only associated with motor improvement in some ...
Advances in Deep Brain Stimulation: From Mechanisms to ...Deep brain stimulation (DBS) is a surgical therapy involving the implantation of electrodes into target brain regions to deliver stimulation.
UF-led study shows deep brain stimulation benefits for ...For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...
Prediction of STN-DBS Electrode Implantation Track in ...Optimal electrophysiological placement of the DBS electrode may lead to better long term clinical outcomes. Inter-subject anatomical variability and ...
The effect of deep brain stimulation in Parkinson's disease ...The presented study evaluates EEG microstates in Parkinson's disease and the effect of DBS of the subthalamic nucleus (STN).
An update on best practice of deep brain stimulation in ...Initial data on STN DBS showed an impressive improvement of the Unified Parkinson's Disease Rating Scale motor subscore (UPDRS-III), by 49–71%, and a marked ...
Correlation between programmed stimulation parameters ...Correlation between programmed stimulation parameters and their efficacy after deep brain electrode implantation for Parkinson's disease.
fda - summary of safety and effectiveness data (ssed)The Infinity DBS System is contraindicated for patients who are unable to operate the system or who have unsuccessful test stimulation. The following procedures ...
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