Assess propofol effects on brain
- Trial ID
- NCT05895019
- Official Title
- Effects of Propofol on Brain Function in Patients With Parkinson's Disease
- Goal
- Assess propofol effects on brain
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- OBSERVATIONAL
- Enrollment
- 600 participants
- Conditions
- PD - Parkinson's Disease
- Interventions
- Propofol
Summary For Families
They are looking at how propofol, the common anesthetic that enhances GABA-A activity and quiets brain electrical signals, changes brain function in people with Parkinson's, especially during procedures like bilateral deep brain stimulation. It's an observational study where propofol is given during surgery and researchers record how it alters neuronal activity; propofol does not boost or block dopamine like levodopa, but by suppressing neural firing it can change the brain signals clinicians rely on for DBS and may affect how symptoms or recordings appear under anesthesia. The trial enrolls adults 18 to 80 years old, ASA class I to III, including people with primary or genetic PD who still respond well to levodopa and are scheduled for bilateral DBS, plus a comparison group of adults without neurological disease having non-neurosurgical, non-cardiac operations, with exclusions for severe sleep apnea, BMI over 30, difficult airways, serious organ failure, or prior major brain injury.
Locations
- Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Propofol. They are looking at how propofol, the common anesthetic that enhances GABA-A activity and quiets brain electrical signals, changes brain function in people with Parkinson's, especially during procedures like bilateral deep brain stimulation. It's an observational study where propofol is given during surgery and researchers record how it alters neuronal activity; propofol does not boost or block dopamine like levodopa, but by suppressing neural firing it can change the brain signals clinicians rely on for DBS and may affect how symptoms or recordings appear under anesthesia. The trial enrolls adults 18 to 80 years old, ASA class I to III, including people with primary or genetic PD who still respond well to levodopa and are scheduled for bilateral DBS, plus a comparison group of adults without neurological disease having non-neurosurgical, non-cardiac operations, with exclusions for severe sleep apnea, BMI over 30, difficult airways, serious organ failure, or prior major brain injury.
- Who can participate?
- Participants must be between 18 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 2 years and 4 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.