Cortical Stimulation for Parkinson's Disease

(PC+S_PFC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Philip Starr

Must be taking: Anti-Parkinsonian

Disqualifiers: Pregnancy, Severe hypertension, Severe diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of anti-Parkinsonian medications for at least 30 days before starting the study. It does not specify if you need to stop other medications, so it's best to discuss this with the study team.

What data supports the effectiveness of the treatment Activa PC+S Prefrontal for Parkinson's Disease?

Research on similar treatments, like deep brain stimulation (DBS), shows that it can improve motor function in Parkinson's Disease. While extradural motor cortex stimulation (EMCS) did not show significant objective benefits, some patients reported subjective improvements in stability and gait. ^{1 2 3 4 5}

What safety data exists for cortical stimulation treatments like Activa PC+S for Parkinson's Disease?

Deep brain stimulation (DBS) devices, including those similar to Activa PC+S, have reported complications such as infections, lead migrations, and device malfunctions. Psychiatric effects like anxiety and depression have also been noted. While many adverse events are not severe, some require additional surgery to address issues. ^{6 7 8 9 10}

How does the Activa PC+S Prefrontal treatment for Parkinson's Disease differ from other treatments?

The Activa PC+S Prefrontal treatment is unique because it involves cortical stimulation, specifically targeting the prefrontal cortex, which is a less invasive alternative to deep brain stimulation (DBS). This approach aims to modulate brain activity and improve motor function without the need for more invasive surgical procedures. ^{3 5 11 12 13}

What is the purpose of this trial?

This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.

Research Team

Simon J Little, MBBS, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for Parkinson's disease patients aged 30-75 with severe movement symptoms despite medication, who may benefit from deep brain stimulators. They should have mood or behavioral issues like depression or anxiety and show improvement on medication. Excluded are pregnant women, those with significant cognitive impairment, prior intracranial surgery (other than DBS), major comorbidities, or conditions that could interfere with the study.

Inclusion Criteria

My Parkinson's symptoms improve by at least 30% when I take my medication.

I have Parkinson's with severe tremor not improved by medication or I can't tolerate the medication.

Have one or several mild to moderate mood or impulsive behavior as defined by: depression (BDI>=13), anxiety (BAI >=7), impulsive behavior as indicated by a positive score on the QUIP-A (Questionnaire for Impulsive-Compulsive disorders in Parkinson's Disease) or as determined by clinical interview or informant report

Exclusion Criteria

Any personality or mood symptoms that study personnel believe will interfere with study requirements.

I have had brain surgery, but not for deep brain stimulation.

My immune system is weak.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Deep brain surgery (DBS) implantation and initial cortical stimulation setup

4 weeks

In-person visits for surgery and setup

Treatment and Monitoring

Cortical stimulation and monitoring of brain signals and symptoms

24 months

Regular in-person and home visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Activa PC+S Prefrontal

Trial Overview The study tests cortical stimulation using Activa PC+S Prefrontal to alleviate mood and behavioral symptoms in Parkinson's patients. Participants will be selected based on specific criteria including their response to medications and severity of symptoms.

Participant Groups

Group I: PD with mood disorder or impulsivity Experimental Treatment 1 Intervention

This is a single-center study of the neurophysiology of non-motor symptoms such as anxiety, depression, and impulsivity that are comorbid in Parkinson's Disease.

Who Is Running the Clinical Trial?

Philip Starr

Lead Sponsor

Trials

1

Recruited

10+

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Simon J. Little, MBBS, PhD

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

In a study of 40 Parkinson's disease patients undergoing subthalamic deep brain stimulation (STN-DBS), 45% reported significant improvement in sleep quality at 6 months, although this improvement was not statistically significant at 12 months.

The most common benefits included better overall sleep quality and maintenance, but some patients experienced new-onset daytime sleepiness, indicating that while STN-DBS can improve sleep, the effects can vary widely among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. Kharkar, S., Ellenbogen, JR., Samuel, M., et al.[2020]

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]

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]

References

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

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. [2020]

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

Parkinson's Disease: Surgical Options. [2020]

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

Therapeutic extradural cortical stimulation for Parkinson's Disease: report of six cases and review of the literature. [2019]

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

Extradural motor cortex stimulation in Parkinson's disease. [2013]

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

Primary motor cortex in Parkinson's disease: Functional changes and opportunities for neurostimulation. [2021]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Local field potential recordings in a non-human primate model of Parkinsons disease using the Activa PC + S neurostimulator. [2018]

8. 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]

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

Long-term efficacy of globus pallidus stimulation for the treatment of Parkinson's disease. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Mood stability in Parkinson disease following deep brain stimulation: a 6-month prospective follow-up study. [2022]

11. Austria pubmed.ncbi.nlm.nih.gov

Extradural cortical stimulation for movement disorders. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Cerebral activity modulation by extradural motor cortex stimulation in Parkinson's disease: a perfusion SPECT study. [2016]

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

Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. [2016]