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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a newly designed microelectrode that measures brain activity in people with Parkinson's disease. Researchers aim to determine if this electrode performs better and is safer than standard ones. The trial targets patients receiving a specific brain implant, known as a Deep Brain Stimulating (DBS) electrode, to alleviate Parkinson's symptoms. The new microelectrode under evaluation is the DBD (Diagnostic Biochips) Deep Array microelectrode. Participants must not have had this implant before and should not have allergies to certain materials.

As an unphased trial, this study provides patients the chance to contribute to groundbreaking research that could enhance future Parkinson's treatments.

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 prior data suggests that this microelectrode is safe for use in Parkinson's Disease?

Research has shown that deep brain stimulation (DBS) devices, such as the DBD Deep Array microelectrode, can sometimes cause issues, including infections or device movement within the brain. However, high-density microelectrodes have demonstrated strong results and good quality in labs for over two years.

Although specific safety data from trials with the DBD Deep Array microelectrode is not available, similar electrodes used in current DBS treatments provide some insight. These devices are generally well-tolerated and undergo continuous study for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DBD Deep Array microelectrode because it offers a groundbreaking way to manage Parkinson's disease by focusing on precise neuronal recording and behavioral testing. Unlike traditional treatments such as medication and deep brain stimulation, which often have broad effects, this microelectrode technology allows for high-density recordings of brain activity, providing targeted insights into the neuronal processes. This level of precision can potentially lead to more personalized treatments, improving outcomes and minimizing side effects for patients.

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

Research has shown that the DBD Deep Array microelectrode, used by participants in this trial, can accurately measure brain cell activity in individuals with Parkinson's disease. This innovative device records signals from both individual nerve cells and groups of cells. Its compact size and multiple channels enable it to access brain areas more effectively than standard electrodes. Accurate placement of these electrodes in deep brain stimulation (DBS) has resulted in improved outcomes for Parkinson's patients. Although this microelectrode is still under evaluation in this trial, its design promises more precise and effective brain recordings. ^{1 2 6 7 8}

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

I am older than 18 years.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05919160

A High-density Microelectrode for Human Neuronal ... 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 ...

2. withpower.com withpower.com/trial/phase-parkinson-disease-6-2023-df794

High-density Microelectrode for Parkinson's Disease 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33497391/

Clinical outcome prediction from analysis of microelectrode ... Conclusion: Clinical improvements in PD patients who underwent bilateral STN DBS could be predicted based on a multitask deep learning-based MER ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084284/

Deep brain stimulation in Parkinson's disease The effectiveness of deep brain stimulation (DBS) for Parkinson's disease (PD) depends on implantation accuracy. DBS initially employed a ...

5. diagnosticbiochips.com diagnosticbiochips.com/deep-array-vs-the-competition

Deep Array Comparison The Deep Array's high-density channel count, small footprint, and long shank outreaches and outperforms the competition. Easily reach any brain area with the ...

6. diagnosticbiochips.com diagnosticbiochips.com/products-deep-array

Product Page: Deep Array Deep Array probes have been the workhorse in my lab for over two years, with consistently strong results. The build quality is excellent.

7. reporter.nih.gov reporter.nih.gov/search/14E8CF034C8AC3D17598B8961CAA4A01A2FFCEB861BF/project-details/10930859

Circuit-based deep brain stimulation for Parkinson's disease We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36567243/

Eleven-Year Outcomes of Deep Brain Stimulation in Early ... This study aims to report the 11-year outcomes of patients who completed the DBS in early-stage PD pilot clinical trial.