Brain Electrode for Parkinson's Disease
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.12345Why 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Recording
Neuropixels probes are inserted and removed during awake Deep Brain Stimulation (DBS) surgery to record neuronal activity
Follow-up
Participants are monitored for safety and effectiveness after the surgery and recording
What Are the Treatments Tested in This Trial?
Interventions
- Brain electrode
- Temporary implantation of large-scale intracranial electrode
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator