Improve cognition through caudate stimulation
- Trial ID
- NCT04715984
- Official Title
- Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
- Goal
- Improve cognition through caudate stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Vanderbilt University Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 75 participants
- Conditions
- Parkinson Disease
- Interventions
- Neurophysiology recordings, Neural stimulation
Summary For Families
The team wants to map how communication between the cortex and the caudate contributes to the thinking and memory problems some people with Parkinson's experience. During awake deep brain stimulation surgery at Vanderbilt, researchers will record electrical activity from the caudate and nearby cortex and deliver brief, controlled stimulation through the planned DBS electrode while you do simple cognitive tests, to see how those circuits respond. They are enrolling adults 40 and older with Parkinson's who are scheduled for DBS under local anesthesia with a clinical electrode trajectory that contacts the caudate, and who can participate in intraoperative testing and speak English. People under 40, those who cannot follow instructions during surgery, or those with a different movement disorder are not eligible.
Locations
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Neurophysiology recordings. The team wants to map how communication between the cortex and the caudate contributes to the thinking and memory problems some people with Parkinson's experience. During awake deep brain stimulation surgery at Vanderbilt, researchers will record electrical activity from the caudate and nearby cortex and deliver brief, controlled stimulation through the planned DBS electrode while you do simple cognitive tests, to see how those circuits respond. They are enrolling adults 40 and older with Parkinson's who are scheduled for DBS under local anesthesia with a clinical electrode trajectory that contacts the caudate, and who can participate in intraoperative testing and speak English. People under 40, those who cannot follow instructions during surgery, or those with a different movement disorder are not eligible.
- Who can participate?
- Participants must be at least 40 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 8 years and 2 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.