High-density Microelectrode for Parkinson's Disease
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the High-density Microelectrode for Parkinson's Disease treatment?
Research shows that using advanced microelectrodes for deep brain stimulation (DBS) can help manage Parkinson's disease by recording brain activity and adjusting stimulation based on individual needs. This approach has been validated in both human and animal studies, suggesting it can improve treatment outcomes by providing more precise and adaptive therapy.12345
What safety data exists for high-density microelectrodes used in deep brain stimulation for Parkinson's disease?
Deep brain stimulation (DBS) devices, which include high-density microelectrodes, have been associated with complications such as infections, lead migrations, and device malfunctions. Infections were the most common issue, affecting 16.2% of cases, and over a third of devices with adverse events required surgical intervention. Further research is needed to improve safety and reduce these complications.24678
How is the DBD Deep Array microelectrode treatment different from other Parkinson's disease treatments?
The DBD Deep Array microelectrode treatment is unique because it uses a high-density microelectrode array to both stimulate and record from multiple brain regions simultaneously, providing detailed insights into brain activity and neurotransmitter release, unlike traditional treatments that typically focus on either stimulation or recording separately.2591011
What is the purpose of this trial?
The purpose of this study is to test the ability of a newly-designed electrode to measure the activity of individual nerve cells (neurons), and collections of nerve cells (local field potentials) in the brain. The study's main goals are to see how well this electrode works compared to standard electrodes and to validate its safety.
Research Team
Adam Mamelak, MD
Principal Investigator
Cedars-Sinai Medical Center
Eligibility Criteria
This trial is for adults over 18 with Parkinson's Disease who are undergoing a Deep Brain Stimulating (DBS) electrode implant in the brain to improve treatment. They must be able to consent and have no allergies to stainless steel or polyimide, nor previous DBS implants at the site.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neuronal Recording and Behavioral Testing
Participants undergo neuronal recording using the high-density microelectrode and behavioral testing
Follow-up
Participants are monitored for safety and effectiveness after the recording procedure
Treatment Details
Interventions
- DBD (Diagnostic Biochips) Deep Array microelectrode
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor