Novel DBS stimulation patterns for Parkinson's (NCT04799470)
Brain stimulation improves motor control
- Trial ID
- NCT04799470
- Official Title
- Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot
- Goal
- Brain stimulation improves motor control
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Nebraska
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson's Disease
- Interventions
- Novel DBS stimulation patterns
Summary For Families
The goal is to see whether new patterns of deep brain stimulation can better target the abnormal beta brain rhythms that underlie Parkinson's motor symptoms, potentially making stimulation more precise for people already helped by DBS. The approach tests novel timing and pulse patterns delivered through your existing Medtronic Percept PC, using the Percept BrainSense survey to detect a robust beta peak (≥ 0.7 µV/rtHz) and see how changing the stimulation pattern interacts with those rhythms while you remain on your usual DBS settings and medications. Adults 19 to 80 with idiopathic Parkinson's who already have bilateral STN DBS with a Percept PC, are at least 3 months post-op with optimized meds and settings, show a good clinical response and a detectable beta peak are eligible; people with implanted cardiac devices, unstable or unusual programming needs, or a Percept flagged for replacement are excluded.
Locations
- Unversity of Nebraska Medical Center, Omaha, Nebraska, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Novel DBS stimulation patterns. The goal is to see whether new patterns of deep brain stimulation can better target the abnormal beta brain rhythms that underlie Parkinson's motor symptoms, potentially making stimulation more precise for people already helped by DBS. The approach tests novel timing and pulse patterns delivered through your existing Medtronic Percept PC, using the Percept BrainSense survey to detect a robust beta peak (≥ 0.7 µV/rtHz) and see how changing the stimulation pattern interacts with those rhythms while you remain on your usual DBS settings and medications. Adults 19 to 80 with idiopathic Parkinson's who already have bilateral STN DBS with a Percept PC, are at least 3 months post-op with optimized meds and settings, show a good clinical response and a detectable beta peak are eligible; people with implanted cardiac devices, unstable or unusual programming needs, or a Percept flagged for replacement are excluded.
- Who can participate?
- Participants must be between 19 Years and 80 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 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.