Clinician-based DBS programming for Parkinson's (NCT07348705)
Reduce tremor slowness and stiffness
- Trial ID
- NCT07348705
- Official Title
- Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease
- Goal
- Reduce tremor slowness and stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Florida
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Clinician-based DBS programming, Maximum Beta power-based DBS programming, Broad-band electrophysiology-based DBS programming
Summary For Families
The team wants to know if using the brain's own electrical signals to guide deep brain stimulation can give more precise, faster relief of motor symptoms like tremor, slowness, and stiffness than usual clinician-led programming. Using the Medtronic Percept DBS, the study compares standard clinician programming to two signal-guided methods, one that sets stimulation where beta-band power is highest and one that uses broader electrophysiology patterns, with the goal of reducing abnormal brain oscillations while patients continue their regular medications. Adults 21 to 89 with idiopathic Parkinson’s who already have a Percept DBS implanted and can consent at their initial programming session are eligible; people with atypical parkinsonism or who cannot follow the protocol are excluded.
Locations
- Norman Fixel Institute for Neurological Diseases, Gainesville, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinician-based DBS programming. The team wants to know if using the brain's own electrical signals to guide deep brain stimulation can give more precise, faster relief of motor symptoms like tremor, slowness, and stiffness than usual clinician-led programming. Using the Medtronic Percept DBS, the study compares standard clinician programming to two signal-guided methods, one that sets stimulation where beta-band power is highest and one that uses broader electrophysiology patterns, with the goal of reducing abnormal brain oscillations while patients continue their regular medications. Adults 21 to 89 with idiopathic Parkinson’s who already have a Percept DBS implanted and can consent at their initial programming session are eligible; people with atypical parkinsonism or who cannot follow the protocol are excluded.
- Who can participate?
- Participants must be between 21 Years and 89 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 1 year.
- 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.
- How many visits does this trial involve?
- The study will be done at the time of the initial programming session.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.