Medtronic Percept Deep Brain Stimu… for Parkinson's (NCT07682311)
Reduce under and over stimulation
- Trial ID
- NCT07682311
- Official Title
- Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator
- Goal
- Reduce under and over stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of California, San Francisco
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- PD - Parkinson's Disease
- Interventions
- Medtronic Percept Deep Brain Stimulation (adaptive DBS), Medtronic Percept Deep Brain Stimulation (cDBS)
Summary For Families
The goal is to cut down times when people with Parkinson’s are under- or over-stimulated by standard therapy and to smooth out remaining problems like slowed movement, involuntary movements, or muscle tightness that persist despite deep brain stimulation. The approach tests an automated, data-driven system that recommends control settings for adaptive deep brain stimulation using the Medtronic Percept neurostimulator; the adaptive system reads brain signals in real time and automatically raises or lowers stimulation within preset limits to match changing needs during the day. Eligible participants are adults 25 to 75 with idiopathic Parkinson’s who already have a Percept device implanted for at least two months, have been on constant deep brain stimulation but still have significant motor fluctuations, and have no significant thinking problems (a score of 24 or higher on the Montreal Cognitive Assessment) and can attend follow-up visits.
Locations
- University of California San Francisco, San Francisco, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Medtronic Percept Deep Brain Stimulation (adaptive DBS). The goal is to cut down times when people with Parkinson’s are under- or over-stimulated by standard therapy and to smooth out remaining problems like slowed movement, involuntary movements, or muscle tightness that persist despite deep brain stimulation. The approach tests an automated, data-driven system that recommends control settings for adaptive deep brain stimulation using the Medtronic Percept neurostimulator; the adaptive system reads brain signals in real time and automatically raises or lowers stimulation within preset limits to match changing needs during the day. Eligible participants are adults 25 to 75 with idiopathic Parkinson’s who already have a Percept device implanted for at least two months, have been on constant deep brain stimulation but still have significant motor fluctuations, and have no significant thinking problems (a score of 24 or higher on the Montreal Cognitive Assessment) and can attend follow-up visits.
- Who can participate?
- Participants must be between 25 Years and 75 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 3 years and 11 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 a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- 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.