Reduce exertion with adaptive stimulation
- Trial ID
- NCT06296810
- Official Title
- Implementation of Adaptive DBS to Offset STN Dysregulation During Exercise and Reduce Exertion in Parkinson's Disease
- Goal
- Reduce exertion with adaptive stimulation
- 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 if adaptive deep brain stimulation can prevent abnormal subthalamic nucleus activity during exercise, so people with Parkinson's feel less exertion and fatigue while moving. The approach uses your already‑implanted Medtronic Sensight leads and Percept IPG to sense STN signals and automatically adjust stimulation strength in real time, stabilizing motor signals during activity rather than relying on a fixed setting, and it is a device change that works alongside your current medications and DBS hardware. The study seeks 20 to 70 year olds who already have a Sensight implant with a Percept IPG, can complete the exercise testing, and can give informed consent, with about 10 people expected to enroll.
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 if adaptive deep brain stimulation can prevent abnormal subthalamic nucleus activity during exercise, so people with Parkinson's feel less exertion and fatigue while moving. The approach uses your already‑implanted Medtronic Sensight leads and Percept IPG to sense STN signals and automatically adjust stimulation strength in real time, stabilizing motor signals during activity rather than relying on a fixed setting, and it is a device change that works alongside your current medications and DBS hardware. The study seeks 20 to 70 year olds who already have a Sensight implant with a Percept IPG, can complete the exercise testing, and can give informed consent, with about 10 people expected to enroll.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.