Improve mood through caudate stimulation

Trial ID
NCT07409207
Official Title
Neurophysiology of Reward Signaling in Parkinson's Disease
Goal
Improve mood 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 goal is to map how reward signaling in the caudate is altered in Parkinson's, because those changes can affect motivation, decision making, and how people respond to treatments. During awake deep brain stimulation surgery at Vanderbilt, researchers will record electrical activity from the caudate and deliver brief, controlled neural stimulation while you do simple tasks, to see how reward circuits fire and react; those recordings can help guide better DBS targeting or future therapies. This work is observational and mapping-focused, not a new drug or long-term treatment. The study is for people age 40 and older with Parkinson's or another movement disorder who are already scheduled for DBS under local anesthesia with an electrode path that contacts the caudate, and who can follow instructions and speak English.

Locations

  • Vanderbilt University Medical Center, Nashville, Tennessee, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying Neurophysiology recordings. The goal is to map how reward signaling in the caudate is altered in Parkinson's, because those changes can affect motivation, decision making, and how people respond to treatments. During awake deep brain stimulation surgery at Vanderbilt, researchers will record electrical activity from the caudate and deliver brief, controlled neural stimulation while you do simple tasks, to see how reward circuits fire and react; those recordings can help guide better DBS targeting or future therapies. This work is observational and mapping-focused, not a new drug or long-term treatment. The study is for people age 40 and older with Parkinson's or another movement disorder who are already scheduled for DBS under local anesthesia with an electrode path that contacts the caudate, and who can follow instructions and speak English.
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 5 years and 1 month.
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.

Related Reading

View on ClinicalTrials.gov