Deep Brain Stimulation Decision Aid for Parkinson's (NCT06446505)
Decision aid improves informed choices
- Trial ID
- NCT06446505
- Official Title
- 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
- Goal
- Decision aid improves informed choices
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Colorado, Denver
- Study Type
- INTERVENTIONAL
- Enrollment
- 42 participants
- Conditions
- Parkinson Disease
- Interventions
- Deep Brain Stimulation Decision Aid
Summary For Families
It tests whether an online decision aid can help people with Parkinson's who are weighing deep brain stimulation surgery find the information acceptable and make a clearer, more informed decision with less uncertainty. Participants are randomly assigned to get the decision aid either at the start of their surgical evaluation or toward the end, and they complete surveys at five visits over about six months to compare the two approaches. Adults 18 and older referred for a deep brain stimulation evaluation at the University of Colorado can join, but people with other Parkinson-like disorders or a diagnosis of dementia are not eligible.
Locations
- University of Colorado Anschutz, Aurora, Colorado, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation Decision Aid. It tests whether an online decision aid can help people with Parkinson's who are weighing deep brain stimulation surgery find the information acceptable and make a clearer, more informed decision with less uncertainty. Participants are randomly assigned to get the decision aid either at the start of their surgical evaluation or toward the end, and they complete surveys at five visits over about six months to compare the two approaches. Adults 18 and older referred for a deep brain stimulation evaluation at the University of Colorado can join, but people with other Parkinson-like disorders or a diagnosis of dementia are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 1 month.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- You will complete surveys at 5 visits (which may be remote or in-person) over approximately 6 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.