Propofol for Parkinson's (NCT05895019)
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?
- 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 2 years and 4 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.