Parkinson's Trial NCT06405334
Predict falls using wearable sensors
- Trial ID
- NCT06405334
- Official Title
- Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease
- Goal
- Predict falls using wearable sensors
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- OBSERVATIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinson's Disease
Summary For Families
The study aims to figure out why balance problems and falls happen in Veterans with Parkinson's, because current tests and treatments do not capture or solve real-world balance loss. Participants wear five small motion sensors and a neck camera for a week while researchers use computer algorithms to label events like walking, turning, standing up, and near-falls, and a smaller group who already have deep brain stimulation electrodes will have those electrodes record the brain's electrical signals during these events. The team will group movement patterns into meaningful types, see which types predict future fall risk or link to other health issues, and look for brain activity that happens just before, during, and after a loss of balance. Veterans with Parkinson's disease who are in stages 2 to 3, age 18 or older, and able to give consent can join; people with severe dementia, other forms of parkinsonism, or significant drops in blood pressure on standing are excluded, and the brain recordings require already having an implanted deep brain stimulation device.
Locations
- Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The study aims to figure out why balance problems and falls happen in Veterans with Parkinson's, because current tests and treatments do not capture or solve real-world balance loss. Participants wear five small motion sensors and a neck camera for a week while researchers use computer algorithms to label events like walking, turning, standing up, and near-falls, and a smaller group who already have deep brain stimulation electrodes will have those electrodes record the brain's electrical signals during these events. The team will group movement patterns into meaningful types, see which types predict future fall risk or link to other health issues, and look for brain activity that happens just before, during, and after a loss of balance. Veterans with Parkinson's disease who are in stages 2 to 3, age 18 or older, and able to give consent can join; people with severe dementia, other forms of parkinsonism, or significant drops in blood pressure on standing are excluded, and the brain recordings require already having an implanted deep brain stimulation device.
- 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 4 years.
- 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.