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?
- 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 4 years and 11 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.