Deep brain stimulation for Parkinson's (NCT04650932)
Brain stimulation reduces thinking problems
- Trial ID
- NCT04650932
- Official Title
- Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
- Goal
- Brain stimulation reduces thinking problems
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of California, Davis
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Deep brain stimulation
Summary For Families
Researchers are testing whether adding low frequency stimulation in the lower part of the subthalamic nucleus can prevent or reduce thinking problems, like trouble finding words, planning, and controlling attention, that sometimes occur with standard deep brain stimulation for Parkinson's while keeping its strong benefit for movement. They will use the already implanted Boston Scientific Vercise deep brain stimulation system to deliver the usual high frequency pulses to the upper subthalamic area for motor benefit and at the same time add low frequency pulses to the lower area, because low frequency brain rhythms called theta are linked to cognitive control. Adults 18 and older with idiopathic Parkinson's who have had the Vercise system implanted for at least three months and whose electrode contacts reach the lower subthalamic area may join. People who cannot consent, who have major cognitive or physical problems that would prevent doing the cognitive tests, who score below 15 on the Montreal Cognitive Assessment blind test, who score above 20 on the Center for Epidemiologic Studies Depression Scale, who are pregnant or prisoners, or who do not speak English are not eligible.
Locations
- UC Davis Health, Sacramento, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep brain stimulation. Researchers are testing whether adding low frequency stimulation in the lower part of the subthalamic nucleus can prevent or reduce thinking problems, like trouble finding words, planning, and controlling attention, that sometimes occur with standard deep brain stimulation for Parkinson's while keeping its strong benefit for movement. They will use the already implanted Boston Scientific Vercise deep brain stimulation system to deliver the usual high frequency pulses to the upper subthalamic area for motor benefit and at the same time add low frequency pulses to the lower area, because low frequency brain rhythms called theta are linked to cognitive control. Adults 18 and older with idiopathic Parkinson's who have had the Vercise system implanted for at least three months and whose electrode contacts reach the lower subthalamic area may join. People who cannot consent, who have major cognitive or physical problems that would prevent doing the cognitive tests, who score below 15 on the Montreal Cognitive Assessment blind test, who score above 20 on the Center for Epidemiologic Studies Depression Scale, who are pregnant or prisoners, or who do not speak English are not eligible.
- 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?
- 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 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?
- 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). Confirm the full schedule with the study coordinator.