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?

This trial aims to determine if a tool called a Decision Aid can assist people with Parkinson's disease in making informed choices about Deep Brain Stimulation (DBS) surgery. Researchers seek to understand whether the Decision Aid simplifies decision-making and reduces stress related to the decision. Participants will receive the Decision Aid either early in the evaluation process or later and will complete surveys over approximately six months. The trial seeks adults with Parkinson's disease who are being considered for DBS surgery, excluding those with atypical forms of Parkinsonism or dementia.

As an unphased trial, this study provides patients the opportunity to contribute to research that could enhance decision-making tools for future DBS candidates.

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.

What prior data suggests that this Decision Aid is safe for patients with Parkinson's disease?

Research has shown that Deep Brain Stimulation (DBS) is generally safe for treating Parkinson's disease. In previous studies, some patients experienced minor side effects, such as slight speech or balance issues, while a few had more noticeable speech problems or a tingling sensation. Despite these effects, most patients tolerate DBS well. This study focuses on a Decision Aid to assist in deciding whether to undergo DBS, and it does not involve any new medical procedures. There are no known safety concerns associated with using this Decision Aid. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Deep Brain Stimulation (DBS) in Parkinson's Disease because it offers a new way to empower patients in making informed decisions about their treatment options. Unlike traditional approaches, where patients might rely solely on medical advice, this decision aid provides detailed, accessible information at different stages of the DBS evaluation process. By doing so, it aims to improve patient understanding and satisfaction, potentially leading to better treatment outcomes and a more personalized treatment journey.

What evidence suggests that this Decision Aid is effective for improving decision quality in Parkinson's disease?

Research has shown that Deep Brain Stimulation (DBS) surgery can improve symptoms in people with Parkinson's disease, particularly those with movement issues. Studies have found that DBS better controls tremors and other movement-related symptoms. In this trial, participants will receive the Decision Aid for DBS at different times to help them make more informed and confident choices about the surgery. Patients who used decision aids in the past felt more knowledgeable and less uncertain about their treatment options. This suggests that the Decision Aid could be a helpful tool for those considering DBS. ^{1 2 3 4 6}

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 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]

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 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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. neurologyevent.ucdenver.edu neurologyevent.ucdenver.edu/documents/dbs/DBS%20Decision%20Aid%20CPPCD.pdf

Deep Brain Stimulation (DBS) Surgery undergone DBS or were considering DBS to get their feedback on the tool. ... Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440024/

An update on best practice of deep brain stimulation in ... Dependent on the patient's needs, either program would provide optimal support (e.g. optimal tremor control while eating, optimal speech during conversation).

3. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=21

Deep Brain Stimulation for Parkinson's Disease Evidence from the nine studies provided outcomes data for GPi DBS among at least 53 patients. ... tool such as the UPDRS for the evaluation of neuropsychological ...

4. withpower.com withpower.com/trial/phase-parkinson-disease-5-2024-291ce?condition=Parkinson%27s+Disease&overallStatus=Recruiting&hasNoPlacebo=false

Decision Aid for Deep Brain Stimulation in Parkinson's ... 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4258408/

Validity and Efficacy of Screening Algorithms for Assessing ... A decision tool to support appropriate referral for deep brain stimulation in Parkinson's disease. J Neurol 2009;256:83–88. [DOI] [PubMed] [Google Scholar] ...

6. neuromodulation.abbott neuromodulation.abbott/us/en/healthcare-professionals/parkinsons.html

DBS Therapy for Parkinson's Disease Our clinical studies support the use of Abbott Infinity™ DBS system as an ... Deep Brain Stimulation (DBS) Therapy. Intended Use. This neurostimulation ...