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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In this research study the researchers want to learn more about brain activity related to speech perception and production in patients with Parkinson's Disease who are undergoing deep brain stimulation (DBS).

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) can have complications, with overall rates exceeding 25%, and permanent neurological issues occurring in 4-6% of cases. Common problems include infections, lead migrations, and device malfunctions, with some cases requiring additional surgery. ^{1 2 3 4 5}

How does deep brain stimulation differ from other treatments for Parkinson's disease?

Deep brain stimulation (DBS) is unique because it involves implanting a device that sends electrical signals to specific areas of the brain to help control movement symptoms in Parkinson's disease. Unlike traditional treatments, adaptive DBS can adjust the stimulation in real-time based on the patient's clinical state, potentially improving outcomes and reducing side effects. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Brain signal data collection for Parkinson's Disease?

Research shows that using brain signal data collection for adaptive deep brain stimulation (DBS) in Parkinson's Disease can help tailor the treatment to individual needs by monitoring brain activity and adjusting stimulation accordingly. This approach has been shown to improve movement control and reduce symptoms by using specific brain signals as feedback to optimize DBS settings. ^{6 11 12 13 14}

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

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]

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]

Citations

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

Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson's disease. [2023]

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

Electrocorticography is superior to subthalamic local field potentials for movement decoding in Parkinson's disease. [2022]

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

What brain signals are suitable for feedback control of deep brain stimulation in Parkinson's disease? [2021]

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

Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Subthalamic beta band suppression reflects effective neuromodulation in chronic recordings. [2021]

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

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

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

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

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

Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and patient outcomes. [2019]

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

Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. [2022]

11. Pakistan pubmed.ncbi.nlm.nih.gov

Effectiveness of deep brain stimulation in Parkinson's disease treatment with Single-center experience in Pakistan. [2023]

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

Periodic Artifact Removal With Applications to Deep Brain Stimulation. [2023]

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

Determination of subthalamic nucleus location by quantitative analysis of despiked background neural activity from microelectrode recordings obtained during deep brain stimulation surgery. [2018]

14. England pubmed.ncbi.nlm.nih.gov

An external portable device for adaptive deep brain stimulation (aDBS) clinical research in advanced Parkinson's Disease. [2023]