High-density Microelectrode for Parkinson's Disease

Overseen By Mia Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Previous DBS, Allergic reactions, others

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

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{1 3 6 10 11}

Who Is on the Research Team?

Adam Mamelak, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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

I am older than 18 years.

I can understand and agree to the study's details on my own.

I am getting a DBS implant for Parkinson's to better locate the STN.

Exclusion Criteria

Microelectrode recording is not indicated

Previous implantation of DBS electrodes in this site

Known allergic reaction to stainless steel or polyimide

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuronal Recording and Behavioral Testing

Participants undergo neuronal recording using the high-density microelectrode and behavioral testing

1 week

1 visit (in-person, in OR)

Follow-up

Participants are monitored for safety and effectiveness after the recording procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• DBD (Diagnostic Biochips) Deep Array microelectrode

Trial Overview The study tests a new high-density microelectrode designed for recording individual and group nerve cell activity in the human brain. It aims to compare its performance and safety against standard electrodes during DBS procedures.

How Is the Trial Designed?

Group I: Neuronal Recording and Behavioral Testing Experimental Treatment 1 Intervention

Neuronal Recording and Behavioral Testing

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson's disease. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Design, Fabrication, Simulation and Characterization of a Novel Dual-Sided Microelectrode Array for Deep Brain Recording and Stimulation. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The use of macroelectrodes in recording cellular spiking activity. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The development of an implantable deep brain stimulation device with simultaneous chronic electrophysiological recording and stimulation in humans. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Using fast-scan cyclic voltammetry to evaluate striatal dopamine release elicited by subthalamic nucleus stimulation. [2020]

6. United States 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. [2023]

7. Austria pubmed.ncbi.nlm.nih.gov

Electrode dysfunctions in patients with deep brain stimulation: a clinical retrospective study. [2011]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Integrity Assessment of a Hybrid DBS Probe that Enables Neurotransmitter Detection Simultaneously to Electrical Stimulation and Recording. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Revealing neuronal function through microelectrode array recordings. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Carbon fiber microelectrodes with multiple sensing elements for in vivo voltammetry. [2019]

11. England pubmed.ncbi.nlm.nih.gov

A silicon based implantable microelectrode array for electrophysiological and dopamine recording from cortex to striatum in the non-human primate brain. [2017]