Brain Electrode for Parkinson's Disease

Overseen By Pamela David Gerecht, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Cognitive impairment, Executive function deficits, others

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

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the brain electrode treatment for Parkinson's disease?

Research shows that electrical stimulation in specific brain areas, like the globus pallidus and subthalamic nucleus, can improve movement problems in Parkinson's disease. This type of treatment, known as deep brain stimulation, has been used successfully for movement disorders, offering benefits like adjustability and reversibility. ^{1 2 3 4 5}

Is the brain electrode treatment generally safe for humans?

Deep brain stimulation (DBS), which involves implanting a brain electrode, has been used for various conditions like Parkinson's disease. Common complications include infections and device issues, with some cases requiring additional surgery. Overall, complication rates can exceed 25%, and permanent neurological issues occur in 4-6% of cases. ^{3 6 7 8 9}

How does the temporary implantation of large-scale intracranial electrodes for Parkinson's disease differ from other treatments?

This treatment involves temporarily placing electrodes in the brain to stimulate specific areas, which is different from traditional drug therapies like levodopa that work by increasing dopamine levels. Unlike permanent surgical options, this method is reversible and can be adjusted to the patient's needs, offering a unique approach to managing symptoms such as tremors and rigidity. ^{2 10 11 12 13}

What is the purpose of this trial?

This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.

Eligibility Criteria

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.

I can stay awake for an extra 25 minutes during surgery.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Implanted Experimental Treatment 2 Interventions

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+

Findings from Research

A first-generation, totally implantable neural interface was successfully used in 5 patients with Parkinson's disease, allowing for both continuous therapeutic stimulation and recording of brain activity over a 1-year period without serious complications.

The device demonstrated the feasibility of acquiring chronic multisite brain signals, which can enhance our understanding of neural networks and potentially improve future neurostimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in 5 patients with Parkinson's disease. Swann, NC., de Hemptinne, C., Miocinovic, S., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for movement disorders. Larson, PS.[2021]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Motor cortex stimulation (MCS) is a promising minimally invasive neurosurgical method for treating advanced Parkinson's disease (PD), showing significant improvements in motor symptoms, particularly axial symptoms and L-dopa-induced dyskinesia, across 13 out of 16 studies involving 130 patients.

MCS has a low risk of complications, especially when performed extradurally, making it a viable alternative to deep brain stimulation (DBS) for PD patients who are not candidates for DBS, with the ability to relieve major PD symptoms bilaterally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive motor cortex stimulation for Parkinson's disease. Lavano, A., Guzzi, G., DE Rose, M., et al.[2022]

References

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

Acute stimulation in the external segment of the globus pallidus improves parkinsonian motor signs. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Neurosurgical methods in treatment of Parkinson disease. Current status]. [2019]

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

Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in 5 patients with Parkinson's disease. [2019]

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

Deep brain stimulation for movement disorders. [2021]

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

Improvement in a quantitative measure of bradykinesia after microelectrode recording in patients with Parkinson's disease during deep brain stimulation surgery. [2006]

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. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

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

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. [2008]

9. 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]

10. Germany pubmed.ncbi.nlm.nih.gov

Neurosurgical interventions in the treatment of idiopathic Parkinson disease: neurostimulation and neural implantation. [2019]

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

Parkinson's Disease: Surgical Options. [2020]

12. France pubmed.ncbi.nlm.nih.gov

[Stereotaxic treatment in Parkinson's disease]. [2006]

13. Italy pubmed.ncbi.nlm.nih.gov

Minimally invasive motor cortex stimulation for Parkinson's disease. [2022]