Decision Aid for Deep Brain Stimulation in Parkinson's Disease

Overseen By Erika Shelton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Atypical Parkinsonism, Dementia

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are: * Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery? * Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision? Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid. Participants will: * Receive the decision aid at the beginning of the evaluation process or towards the end * Complete surveys at 5 visits (remote or in-person) over approximately 6 months

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) can have complications such as infections, device malfunctions, and lead migrations, with some cases requiring additional surgery. Overall, complication rates can exceed 25%, and serious long-term effects occur in 4-6% of cases. More research is needed to improve safety and reduce these risks. ^{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 surgically implanting electrodes in the brain to send electrical impulses, which can help control movement symptoms in Parkinson's disease. Unlike medications that are taken orally, DBS directly targets brain areas responsible for movement, offering a more precise treatment option for patients with advanced symptoms. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Deep Brain Stimulation Decision Aid for Parkinson's Disease?

Deep Brain Stimulation (DBS) has been shown to be an effective treatment for Parkinson's disease, especially when applied earlier in the disease course, as it can improve quality-adjusted life expectancy. Tools like the Stimulus and MAP DBS help in selecting appropriate candidates and optimizing DBS programming, enhancing the treatment's effectiveness. ^{6 11 12 13 14}

Who Is on the Research Team?

Michelle E Fullard, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients considering Deep Brain Stimulation surgery. Participants will use a Decision Aid tool and complete surveys over 6 months to see if it helps in their decision-making process.

Inclusion Criteria

I have Parkinson's and am being evaluated for brain surgery at the University of Colorado.

Exclusion Criteria

I have been diagnosed with atypical Parkinsonism.

I have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants receive the decision aid at the beginning or towards the end of the evaluation process for deep brain stimulation surgery

6 months

5 visits (remote or in-person)

Follow-up

Participants are monitored for decision quality and satisfaction after the decision regarding deep brain stimulation surgery

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation Decision Aid

Trial Overview The study tests whether a Decision Aid can make it easier for Parkinson's patients to decide on undergoing brain surgery. It compares the effects of receiving this aid early or later during the surgical evaluation.

How Is the Trial Designed?

Group I: Early Decision Aid Experimental Treatment 1 Intervention

Participants will receive the Decision Aid at baseline.

Group II: Delayed Decision Aid Active Control 1 Intervention

Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

The Mobile Application for PD DBS (MAP DBS) significantly reduced the initial programming visit time for deep brain stimulation in Parkinson's disease patients, making the process more efficient (43.8 minutes for standard care vs. 27.4 minutes for MAP DBS).

Patients using MAP DBS experienced a greater improvement in motor symptoms, as measured by the UPDRS III on-medication scores, compared to those receiving standard care, indicating enhanced clinical efficacy of the programming method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial. Duffley, G., Szabo, A., Lutz, BJ., et al.[2023]

An electronic decision tool was developed to help neurologists identify appropriate candidates for Deep Brain Stimulation (DBS) in patients with advanced Parkinson's disease, based on assessments of 972 theoretical patient profiles.

The tool indicated that referral for DBS was appropriate for 33% of profiles, with factors like symptom severity and duration of Parkinson's disease positively influencing appropriateness, while age over 70, cognitive impairment, and levodopa-resistant symptoms negatively impacted the decision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision tool to support appropriate referral for deep brain stimulation in Parkinson's disease. Moro, E., Allert, N., Eleopra, R., et al.[2022]

In a multicenter study involving deep brain stimulation (DBS) for Parkinson's disease, a neuroanatomically based computer model provided DBS settings that resulted in similar improvements in motor function (UPDRS-III scores) compared to traditional programming methods, with no significant difference in efficacy.

The Model approach not only matched the clinical settings in effectiveness but also reduced programming time significantly (31 seconds vs. 41.4 minutes) and required less power consumption (48.7 μW vs. 76.1 μW), suggesting it could enhance the efficiency of DBS programming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-Based Deep Brain Stimulation Programming for Parkinson's Disease: The GUIDE Pilot Study. Pourfar, MH., Mogilner, AY., Farris, S., et al.[2015]

The online screening tool (Stimulus) effectively assists general neurologists in identifying appropriate candidates for deep brain stimulation (DBS) in Parkinson's disease, with a high sensitivity of 99%.

Despite the tool's effectiveness, only 28% of patients referred after screening actually underwent DBS, primarily due to their reluctance to have brain surgery, highlighting a significant barrier to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tool to improve pre-selection for deep brain stimulation in patients with Parkinson's disease. Wächter, T., Mínguez-Castellanos, A., Valldeoriola, F., et al.[2022]

Early subthalamic nucleus deep brain stimulation (STN DBS) in patients with Parkinson's disease (PD) is associated with a greater quality-adjusted life expectancy of 22.3 QALYs, compared to 19.8 QALYs for delayed surgery, suggesting that earlier intervention may be more beneficial.

The analysis, based on a model using data from 22 STN-DBS and 21 non-STN-DBS patients, indicates that early STN DBS is preferred in 69% of simulations, highlighting its potential effectiveness in improving life quality before significant disability occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed bilateral subthalamic deep brain stimulation for parkinson's disease: a decision analysis. Espay, AJ., Vaughan, JE., Marras, C., et al.[2021]

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]

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]

In a retrospective analysis of 153 deep brain stimulation (DBS) cases over 10 years, the overall complication rate was 15.6%, with most complications being minor and not leading to long-term issues.

The study found that while confusion was more common in elderly patients (≥65 years), the complication rates for DBS surgery were similar across age groups, indicating that DBS is a relatively safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term surgical and hardware-related complications of deep brain stimulation. Doshi, PK.[2022]

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

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]

The Neurostimulation Uncertainty Viewer (nuView) tool was developed to analyze data from deep brain stimulation (DBS) by visualizing the volume of tissue activated (VTA) and correlating it with patient outcomes, specifically using the Unified Parkinson's Disease Rating Scale (UPDRS).

This tool allows for better exploration of the activated tissue, which can lead to improved understanding and optimization of electrode placements in DBS therapy, potentially enhancing treatment effectiveness for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualization for Understanding Uncertainty in Activation Volumes for Deep Brain Stimulation. Hollister, BE., Duffley, G., Butson, C., et al.[2020]

StimExplorer is a new software tool designed to help clinicians optimize deep brain stimulation (DBS) parameters for Parkinson's disease treatment by providing a detailed 3D model of the activated brain tissue volume based on individual patient MRI data.

The software aims to enhance the customization of DBS therapy, making it easier for clinicians to understand how different stimulation settings affect treatment outcomes, ultimately improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing deep brain stimulation parameter selection with detailed models of the electrode-tissue interface. McIntyre, CC., Butson, CR., Maks, CB., et al.[2020]

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]

The new Duality software enables near-real-time computation and visualization of deep brain stimulation (DBS) simulations on tablet devices, making it more accessible for clinical use compared to previous desktop-only options.

This innovative pipeline can significantly streamline the process of optimizing DBS settings for patients, potentially reducing the time and number of clinic visits required for effective treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive computation and visualization of deep brain stimulation effects using Duality. Vorwerk, J., McCann, D., Krüger, J., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

A decision tool to support appropriate referral for deep brain stimulation in Parkinson's disease. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Model-Based Deep Brain Stimulation Programming for Parkinson's Disease: The GUIDE Pilot Study. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

A tool to improve pre-selection for deep brain stimulation in patients with Parkinson's disease. [2022]

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

Early versus delayed bilateral subthalamic deep brain stimulation for parkinson's disease: a decision analysis. [2021]

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

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

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. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term surgical and hardware-related complications of deep brain stimulation. [2022]

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

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. [2020]

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

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Visualization for Understanding Uncertainty in Activation Volumes for Deep Brain Stimulation. [2020]

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

Optimizing deep brain stimulation parameter selection with detailed models of the electrode-tissue interface. [2020]

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

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

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

Interactive computation and visualization of deep brain stimulation effects using Duality. [2021]