42 Participants Needed

Decision Aid for Deep Brain Stimulation in Parkinson's Disease

ME
ES
Overseen ByErika Shelton
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.678910

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.211121314

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

Research Team

ME

Michelle E Fullard, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Decision AidExperimental Treatment1 Intervention
Participants will receive the Decision Aid at baseline.
Group II: Delayed Decision AidActive Control1 Intervention
Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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 ฮผW vs. 76.1 ฮผW), suggesting it could enhance the efficiency of DBS programming.
Model-Based Deep Brain Stimulation Programming for Parkinson's Disease: The GUIDE Pilot Study.Pourfar, MH., Mogilner, AY., Farris, S., et al.[2015]

References

Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial. [2023]
A decision tool to support appropriate referral for deep brain stimulation in Parkinson's disease. [2022]
Model-Based Deep Brain Stimulation Programming for Parkinson's Disease: The GUIDE Pilot Study. [2015]
A tool to improve pre-selection for deep brain stimulation in patients with Parkinson's disease. [2022]
Early versus delayed bilateral subthalamic deep brain stimulation for parkinson's disease: a decision analysis. [2021]
Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. [2008]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Long-term surgical and hardware-related complications of deep brain stimulation. [2022]
Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. [2020]
Safety considerations for deep brain stimulation: review and analysis. [2007]
Visualization for Understanding Uncertainty in Activation Volumes for Deep Brain Stimulation. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Optimizing deep brain stimulation parameter selection with detailed models of the electrode-tissue interface. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. [2022]
Interactive computation and visualization of deep brain stimulation effects using Duality. [2021]
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