Neurophysiology recordings for Parkinson's (NCT04715984)
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?
- 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 8 years and 2 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); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.