Medtronic Percept Deep Brain Stimu… for Parkinson's (NCT07398157)
Personalize brain stimulation for movement
- Trial ID
- NCT07398157
- Official Title
- Subgaleal Cortical Electrodes in Patients With Parkinson's Disease Undergoing Deep-brain Stimulation Therapy for Sensing and Adaptive Deep-brain Stimulation Over a 24-hour Period.
- Goal
- Personalize brain stimulation for movement
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of California, San Francisco
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- PD - Parkinson's Disease
- Interventions
- Medtronic Percept Deep Brain Stimulation (cDBS), Medtronic Percept Deep Brain Stimulation (daytime aDBS), Medtronic Percept Deep Brain Stimulation (nighttime aDBS)
Summary For Families
They are testing whether adding thin sensing electrodes under the scalp can let deep-brain stimulation adjust itself over a full 24 hours to reduce daytime off periods, troublesome dyskinesias, and sleep-related problems. The Medtronic Percept system records cortical rhythms from the subgaleal electrodes and runs closed-loop adaptive DBS that increases stimulation when brain signals predict an off state or motor symptoms and reduces stimulation during good on periods or sleep, so it is designed to work alongside levodopa rather than replace it. Adults 25 to 75 with idiopathic Parkinson's who are DBS candidates, have motor fluctuations despite optimized medications with at least two hours per day of off time or on time with dyskinesias, a normal brain MRI, and preserved cognition (MoCA 24 or higher) are being recruited. People with major medical or psychiatric risks, MR-incompatible implants, or other surgical contraindications are excluded, and about 24 participants will be enrolled.
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 (cDBS). They are testing whether adding thin sensing electrodes under the scalp can let deep-brain stimulation adjust itself over a full 24 hours to reduce daytime off periods, troublesome dyskinesias, and sleep-related problems. The Medtronic Percept system records cortical rhythms from the subgaleal electrodes and runs closed-loop adaptive DBS that increases stimulation when brain signals predict an off state or motor symptoms and reduces stimulation during good on periods or sleep, so it is designed to work alongside levodopa rather than replace it. Adults 25 to 75 with idiopathic Parkinson's who are DBS candidates, have motor fluctuations despite optimized medications with at least two hours per day of off time or on time with dyskinesias, a normal brain MRI, and preserved cognition (MoCA 24 or higher) are being recruited. People with major medical or psychiatric risks, MR-incompatible implants, or other surgical contraindications are excluded, and about 24 participants will be enrolled.
- 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?
- 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 8 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); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.