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?

This trial tests a new approach for Parkinson's disease using a special brain stimulation called Dual Frequency Stimulation. Researchers aim to determine if applying both low and high frequency stimulations to different brain areas can enhance movement and cognitive abilities without side effects. They seek participants with Parkinson's who already have a specific brain implant and have undergone surgery for movement issues. This study may provide new hope for managing both movement and cognitive challenges in Parkinson's. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to innovative Parkinson's treatments.

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.

What prior data suggests that this dual frequency stimulation is safe for Parkinson's disease patients?

In a previous study, patients with Parkinson's disease who received dual frequency stimulation reported improvements in movement issues such as walking and balance. This treatment uses both low and high frequency electrical signals in different parts of the brain. Although concerns exist about possible effects on thinking and speaking, many patients still felt better overall.

Research has shown that adaptive deep brain stimulation (DBS), similar to dual frequency stimulation, greatly improved patients' overall well-being. While no major changes occurred in some thinking skills, the treatment was generally well-tolerated.

In summary, dual frequency stimulation has been mostly safe for participants in studies. Some side effects related to thinking and speaking have been noted, but many patients still experienced better movement and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Dual Frequency Stimulation for Parkinson's Disease because it offers a novel approach compared to existing treatments like medication and traditional deep brain stimulation (DBS). Unlike standard DBS, which typically uses a single frequency to modulate brain activity, this experimental treatment employs dual frequency stimulation, potentially improving motor control by targeting different neural pathways simultaneously. This technique could provide more precise and effective symptom relief for patients, addressing limitations of current options and enhancing quality of life.

What evidence suggests that dual frequency stimulation is effective for Parkinson's disease?

Research shows that dual frequency deep brain stimulation (DBS), which participants in this trial will receive, may help treat Parkinson's disease (PD). Studies have found that this method can improve walking, balance, and speech for many people with PD. Some patients experienced better thinking abilities with low frequency DBS, although it might worsen movement. Another study noted that most patients had better overall movement, and some had fewer involuntary movements, known as dyskinesias. However, DBS doesn't significantly improve balance problems for everyone with PD. ^{1 5 6 7 8}

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]

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 (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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6858889/

A Novel Dual-Frequency Deep Brain Stimulation Paradigm ... A substantial number of patients remained on IL–IL because of subjective improvements in gait/balance, speech, or PD symptoms. A prospective, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04650932

Dual Frequency Stimulation in Parkinson's Disease Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes.

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30254

Low/High Multi‐Frequency Stimulation of the Subthalamic ... Low frequency DBS can improve cognition, but its effects on motor functions are detrimental. Objective. Our goal was to evaluate the effect on ...

4. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... General movement improved in five of seven patients, with significant effects in three. Dyskinesia severity decreased in four patients (one ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024005837

Effectiveness of Deep Brain Stimulation in Improving ... Current research suggests that DBS results in no significant improvement in balance dysfunction for people with PD.

6. trialx.com trialx.com/clinical-trials/listings/244788/dual-frequency-stimulation-in-parkinsons-disease/

Dual Frequency Stimulation in Parkinson's Disease Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397205/

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

8. nature.com nature.com/articles/s41531-024-00772-5

Sensing data and methodology from the Adaptive DBS ... The ADAPT-PD trial sensing data indicate a high LFP signal presence in both on and off medication states of these patients, with bilateral ...