Deep Brain Stimulation for Parkinson's Disease

Overseen By Irene Lerman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-English-speaking

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of single DBS surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how Parkinson's Disease affects brain activity related to speech during deep brain stimulation (DBS). DBS involves placing electrodes in the brain to help manage Parkinson's symptoms. The study collects brain signal data during this procedure. Individuals with a confirmed Parkinson’s diagnosis who are scheduled for DBS surgery may qualify. Participants must speak English and be able to follow instructions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatments for Parkinson's Disease.

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 brain signal data collection during deep brain stimulation is safe for patients with Parkinson's Disease?

Research has shown that deep brain stimulation (DBS) is generally safe for treating Parkinson's disease, though some risks exist. Studies indicate that DBS carries low risk when patients are carefully selected, but the likelihood of hospitalization increases. This is primarily due to the brain surgery involved, which can sometimes lead to serious complications like brain bleeding, stroke, or seizures. However, most patients recover well. For example, one study found that 98.6% of patients were still alive three years after DBS, and 96.4% were alive after five years. While DBS has known risks, it remains a well-established treatment for Parkinson's, and many patients tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of brain signal data collection during deep brain stimulation for Parkinson's disease because it offers a new way to understand and potentially improve treatment. Unlike standard treatments such as medication or surgery, this approach focuses on gathering real-time data about how the brain responds to stimulation, which could lead to more precise and effective interventions. This technique holds promise for tailoring treatments to individual patients, potentially improving symptom management and quality of life for those with Parkinson's.

What evidence suggests that deep brain stimulation is effective for Parkinson's Disease?

Studies have shown that deep brain stimulation (DBS) can greatly help people with Parkinson's Disease. Research indicates that DBS improves movement by about 29%, allowing patients to move better even without their medication. It also boosts quality of life by 26% compared to those who only take medication. Another study showed that these benefits in movement and quality of life can last up to five years. While DBS doesn't stop the disease from progressing, it can make daily life much easier for many patients. In this trial, participants will undergo brain signal data collection during DBS to further understand its effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert M Richardson, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-85 with Parkinson's Disease who are scheduled for Deep Brain Stimulation (DBS) implantation. Participants must be able to understand the study and follow instructions.

Inclusion Criteria

I am scheduled for a DBS implant for my Parkinson's disease.

Subjects able to provide informed consent and comply with task instructions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Collection of brain data during deep brain stimulation surgery

Duration of single DBS surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain signal data collection

Trial Overview The study aims to gather data on brain activity related to speech in Parkinson's patients during DBS. Researchers will use this information to better understand how DBS affects speech perception and production.

How Is the Trial Designed?

Group I: Brain signal data collection Experimental Treatment 1 Intervention

Collection of brain data during deep brain stimulation

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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]

Deep brain stimulation (DBS) is an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

In a study of 319 patients treated with deep brain stimulation (DBS) for various movement disorders over a 10-year period, the procedure demonstrated a favorable safety profile with rare intraoperative adverse events, such as vasovagal response (2.5%) and syncope (1.2%).

Long-term complications were also relatively low, with persistent issues like dysarthria and cognitive dysfunction occurring in about 4% of patients, indicating that DBS is a safe option for treating medically refractory movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. Kenney, C., Simpson, R., Hunter, C., et al.[2022]

In a study involving 11 Parkinson's disease patients, researchers found that using electrocorticography (ECoG) for brain signal decoding was more effective than subthalamic local field potentials (LFP) in predicting grip-force, which is important for movement control.

The study also revealed that the performance of ECoG-based decoding was negatively affected by the patients' motor impairments, suggesting that the underlying pathophysiology of Parkinson's disease influences how well the brain can encode movement, which is crucial for developing personalized brain-computer interfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocorticography is superior to subthalamic local field potentials for movement decoding in Parkinson's disease. Merk, T., Peterson, V., Lipski, WJ., et al.[2022]

In a pilot study involving 7 participants with Parkinson's disease, computer-guided deep brain stimulation (DBS) programming significantly improved motor symptoms, reducing tremor and bradykinesia by an average of 35.7% compared to baseline.

The use of motion sensors to guide DBS programming allowed for optimal stimulation settings to be determined with minimal clinician involvement, suggesting a potential for broader access to effective treatment for patients without specialized care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. Heldman, DA., Pulliam, CL., Urrea Mendoza, E., et al.[2022]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ... Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3843969/

Deep brain stimulation for the treatment of Parkinson's ... Off medication motor function (29%) and measures of quality of life (18%) were also improved for DBS compared with best medical therapy, but there was no ...

3. ohsu.edu ohsu.edu/brain-institute/dbs-outcomes

DBS Outcomes | Brain Institute Improved quality of life: The same study found a 26% improvement in quality-of-life scores among DBS patients, compared to a 1% decline in patients taking ...

4. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

Five-Year Outcomes from Deep Brain Stimulation of the ... From screening, a significant improvement in motor outcomes is reported 1 year after deep brain stimulation (DBS) and sustained out to 5 years.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/p150031b.pdf

summary of safety and effectiveness data (ssed) The following is a list of known risks with the use of Deep Brain Stimulation for the treatment of Parkinson's disease. There may be risks that are unknown.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690827/

Deep brain stimulation in PD: risk of complications ... It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...

8. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-parkinsons-disease/important-safety-information.html

DBS for Parkinson's - Important Safety Information Placing the DBS system requires brain surgery, which can have serious and sometimes fatal complications including bleeding inside the brain, stroke, seizures, ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The current supplement (S478) introduces a new optional programming feature called adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5472429/

The safety issues and hardware-related complications of ... The results showed a 3-year survival rate of 98.6% and a 5-year survival rate of 96.4% for patients with PD who underwent DBS treatment at the study center.