Helping Parkinson's patients decide on Deep Brain Stimulation surgery
Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
This study is testing a tool to help people with Parkinson's disease make better decisions about Deep Brain Stimulation surgery by giving it to them at different times during their evaluation process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06446505 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a Decision Aid designed to assist patients with Parkinson's disease in making informed choices about Deep Brain Stimulation surgery. Participants will either receive the Decision Aid at the start of their evaluation process or at the end, allowing researchers to compare the impact on decision quality and patient uncertainty. Surveys will be conducted over approximately six months to assess the acceptability and effectiveness of the Decision Aid.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with Parkinson's disease who are being evaluated for Deep Brain Stimulation surgery.
Not a fit: Patients with atypical Parkinsonism or a diagnosis of dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients with Parkinson's disease to make more informed and confident decisions regarding their treatment options.
How similar studies have performed: While the use of decision aids in medical settings is gaining traction, this specific approach for Parkinson's disease and Deep Brain Stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado Exclusion Criteria: * Atypical Parkinsonism * Diagnosis of Dementia
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Michelle E Fullard, MD — University of Colorado, Denver
- Study coordinator: Michelle E Fullard, MD
- Email: michelle.fullard@cuanschutz.edu
- Phone: 3037242194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.