Combined STN+NBM DBS for Parkinson's (NCT05968703)
Improve thinking with brain stimulation
- Trial ID
- NCT05968703
- Official Title
- Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
- Goal
- Improve thinking with brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Helen M. Bronte-Stewart
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Interventions
- Combined STN+NBM DBS
Summary For Families
This trial is testing whether adding stimulation in two brain areas, the Subthalamic Nucleus and the Nucleus Basalis of Meynert, is safe and tolerable for treating thinking and thinking-plus-movement problems in people with Parkinson's who have mild cognitive impairment. The plan modifies standard deep brain stimulation for movement by placing four stimulation leads, two in the usual movement target and two in the Nucleus Basalis of Meynert, and uses new patterns of stimulation controlled by research software to target cognitive and cognitive-motor symptoms. Participants will be followed for two years with cognitive tests, walking and movement tasks, and questionnaires every six months, and half the group will be randomized to one of two surgical paths to compare effects. The study seeks 21 to 80-year-old adults with Parkinson's and mild cognitive impairment who are approved or planning to get Subthalamic Nucleus deep brain stimulation; people with dementia, unstable medical or psychiatric issues, a history of seizures, pregnancy, a need for magnetic resonance imaging, or who cannot walk 100 feet without an assistive device are excluded.
Locations
- Stanford Neuroscience Health Center, Stanford, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Combined STN+NBM DBS. This trial is testing whether adding stimulation in two brain areas, the Subthalamic Nucleus and the Nucleus Basalis of Meynert, is safe and tolerable for treating thinking and thinking-plus-movement problems in people with Parkinson's who have mild cognitive impairment. The plan modifies standard deep brain stimulation for movement by placing four stimulation leads, two in the usual movement target and two in the Nucleus Basalis of Meynert, and uses new patterns of stimulation controlled by research software to target cognitive and cognitive-motor symptoms. Participants will be followed for two years with cognitive tests, walking and movement tasks, and questionnaires every six months, and half the group will be randomized to one of two surgical paths to compare effects. The study seeks 21 to 80-year-old adults with Parkinson's and mild cognitive impairment who are approved or planning to get Subthalamic Nucleus deep brain stimulation; people with dementia, unstable medical or psychiatric issues, a history of seizures, pregnancy, a need for magnetic resonance imaging, or who cannot walk 100 feet without an assistive device are excluded.
- Who can participate?
- Participants must be between 21 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 1 year and 10 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- You will be followed for two years with assessments at baseline and every six months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.