Improve attention memory and walking
- Trial ID
- NCT05968703
- Official Title
- Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
- Goal
- Improve attention memory and walking
- 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
The goal is to treat the cognitive-motor syndrome in Parkinson's, where trouble with attention, memory and multitasking makes walking and daily activities harder. Surgeons will implant deep brain stimulation electrodes in both the subthalamic nucleus to control motor symptoms and the nucleus basalis of Meynert to stimulate cholinergic pathways; NBM stimulation aims to boost cortical acetylcholine to improve attention, executive function and dual-task walking. The stimulator is used alongside usual Parkinson's medications, and you may be asked to temporarily stop meds for certain research visits so researchers can measure effects clearly. The trial is looking for people ages 21 to 80 with Parkinson's who are approved or planning for STN DBS, can give consent and pause meds for visits, and who do not have dementia, uncontrolled psychiatric illness, a seizure history, pregnancy, or need an assistive device to walk 100 feet.
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. The goal is to treat the cognitive-motor syndrome in Parkinson's, where trouble with attention, memory and multitasking makes walking and daily activities harder. Surgeons will implant deep brain stimulation electrodes in both the subthalamic nucleus to control motor symptoms and the nucleus basalis of Meynert to stimulate cholinergic pathways; NBM stimulation aims to boost cortical acetylcholine to improve attention, executive function and dual-task walking. The stimulator is used alongside usual Parkinson's medications, and you may be asked to temporarily stop meds for certain research visits so researchers can measure effects clearly. The trial is looking for people ages 21 to 80 with Parkinson's who are approved or planning for STN DBS, can give consent and pause meds for visits, and who do not have dementia, uncontrolled psychiatric illness, a seizure history, pregnancy, or need an assistive device to walk 100 feet.
- 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?
- 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 1 year and 10 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.