aDBS for Parkinson's (NCT06296810)
Prevent symptom worsening during exercise
- Trial ID
- NCT06296810
- Official Title
- Implementation of Adaptive DBS to Offset STN Dysregulation During Exercise and Reduce Exertion in Parkinson's Disease
- Goal
- Prevent symptom worsening during exercise
- Status
- RECRUITING
- Sponsor
- University of Colorado, Denver
- Study Type
- OBSERVATIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- aDBS
Summary For Families
The goal is to see how exercise changes brain activity in Parkinson's and whether a responsive form of deep brain stimulation can prevent symptoms from getting worse during exercise and recovery. Researchers will use the Percept PC neurostimulator to record signals from the brain area targeted by stimulation, the subthalamic nucleus, watch a specific low beta rhythm (13 to 20 cycles per second), and then try adaptive deep brain stimulation that adjusts in response to that rhythm to test feasibility. The study is looking for people with Parkinson who already have a Medtronic Sensight deep brain stimulation implant and a Percept implantable pulse generator, are 20 to 70 years old, can complete the exercise tests, and can give informed consent.
Locations
- University of Colorado, Aurora, Colorado, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying aDBS. The goal is to see how exercise changes brain activity in Parkinson's and whether a responsive form of deep brain stimulation can prevent symptoms from getting worse during exercise and recovery. Researchers will use the Percept PC neurostimulator to record signals from the brain area targeted by stimulation, the subthalamic nucleus, watch a specific low beta rhythm (13 to 20 cycles per second), and then try adaptive deep brain stimulation that adjusts in response to that rhythm to test feasibility. The study is looking for people with Parkinson who already have a Medtronic Sensight deep brain stimulation implant and a Percept implantable pulse generator, are 20 to 70 years old, can complete the exercise tests, and can give informed consent.
- Who can participate?
- Participants must be between 20 Years and 70 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 1 year and 3 months.
- 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). Confirm the full schedule with the study coordinator.