Deep Brain Stimulation for Parkinson's Disease

Overseen By Janice Wang-Polagruto, PhD, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Cognitive impairments, Depression, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.

Will I have to stop taking my current medications?

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.

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections, device malfunctions, and lead migrations. Some patients may experience psychiatric effects like anxiety or depression, and about 4-6% may have permanent neurological issues. ^{1 2 3 4 5}

How is Dual Frequency Stimulation different from other treatments for Parkinson's disease?

Dual Frequency Stimulation is unique because it uses a multiple-source, constant-current device that allows for a precise distribution of electrical current, potentially leading to better motor improvement in Parkinson's patients compared to traditional single-source deep brain stimulation. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Dual Frequency Stimulation for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) with different frequency patterns can effectively manage motor symptoms in Parkinson's disease. Studies suggest that varying the frequency and pattern of DBS can enhance its effectiveness, indicating that Dual Frequency Stimulation might offer similar benefits. ^{6 9 11 12 13}

Who Is on the Research Team?

Kiarash Shahlaie, MD, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults with advanced Parkinson's Disease who have had a specific type of deep brain stimulation (DBS) surgery using the Boston Scientific VerciseTM system. They must be able to consent, participate in cognitive tests, and not have severe cognitive or physical impairments.

Inclusion Criteria

I have Parkinson's and received a Boston Scientific Vercise DBS implant.

You have had the Boston Scientific VerciseTM DBS system implanted for at least 3 months.

I have advanced Parkinson's and underwent DBS surgery targeting the STN for motor improvement.

Exclusion Criteria

I am unable to give consent for myself.

I do not have cognitive or physical impairments that limit my participation in tests.

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dual frequency stimulation of the subthalamic nucleus to assess safety, tolerability, and efficacy

6 months

Regular visits at Week 2, Week 6, Month 3, and Month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Frequency Stimulation

Trial Overview The study is testing low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with Parkinson's. It aims to see if this can improve cognition without worsening motor symptoms.

How Is the Trial Designed?

Group I: Sustained Dual Frequency, Dual Region, Stimulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

The study involving 53 patients with Parkinson's disease showed that a new multiple-source, constant-current deep brain stimulation (DBS) system significantly improved motor symptoms, with a mean reduction of 23.8 points in the UPDRS III score after 6 months.

The safety profile of the DBS system was acceptable, with only 18 serious adverse events reported, all of which resolved without lasting effects, indicating that the device is a promising option for managing Parkinson's motor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Timmermann, L., Jain, R., Chen, L., et al.[2022]

Temporally non-regular patterns of deep brain stimulation (DBS) were found to be as effective as traditional fixed-frequency stimulation in managing motor symptoms like tremor and bradykinesia in Parkinson's disease patients.

Using stimulation gaps of 50 ms not only maintained effective symptom control but also allowed for longer recordings of local evoked potentials, suggesting a potential for more efficient and responsive DBS systems in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporally non-regular patterns of deep brain stimulation (DBS) enhance assessment of evoked potentials while maintaining motor symptom management in Parkinson's disease (PD). Palopoli-Trojani, K., Schmidt, SL., Baringer, KD., 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]

Deep brain stimulation (DBS) for Parkinson's disease, particularly targeting the subthalamic nucleus (STN), provides significant motor improvement and allows for reduced medication doses, making it a preferred option for younger patients with motor complications.

While STN DBS has advantages like better motor control and lower current consumption, it requires more intensive postoperative management and carries risks such as infection and hematoma, though the overall benefit-to-risk ratio is considered favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. Pollak, P., Fraix, V., Krack, P., et al.[2019]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Tremor reduction and modeled neural activity during cycling thalamic deep brain stimulation. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. [2022]

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

Temporally non-regular patterns of deep brain stimulation (DBS) enhance assessment of evoked potentials while maintaining motor symptom management in Parkinson's disease (PD). [2023]

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

Effect of bilateral subthalamic electrical stimulation in Parkinson's disease. [2019]

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

Effects of deep brain stimulation frequency on bradykinesia of Parkinson's disease. [2014]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Treatment results: Parkinson's disease. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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

9. 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]

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

Complications and adverse effects of deep brain stimulation in Parkinson's patients. [2009]

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

What the future holds for deep brain stimulation. [2007]

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

Deep brain stimulation for Parkinson's disease. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Neurological and technical aspects of deep brain stimulation]. [2021]