Decision Aid for Deep Brain Stimulation in Parkinson's Disease
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Evaluation
Participants receive the decision aid at the beginning or towards the end of the evaluation process for deep brain stimulation surgery
Follow-up
Participants are monitored for decision quality and satisfaction after the decision regarding deep brain stimulation surgery
Treatment Details
Interventions
- Deep Brain Stimulation Decision Aid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator