general anesthesia for Parkinson's (NCT05550714)
Confirm tremor control under anesthesia
- Trial ID
- NCT05550714
- Official Title
- Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
- Goal
- Confirm tremor control under anesthesia
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 188 participants
- Conditions
- PD - Parkinson's Disease, Dexmedetomidine, Desflurane, Deep Brain Stimulation
- Interventions
- general anesthesia, Conscious sedation
Summary For Families
The trial is testing whether general anesthesia with desflurane changes the brain-mapping signals used during deep brain stimulation of a small area called the subthalamic nucleus, and whether any signal differences affect clinical results six months after surgery. Patients are randomly assigned to either conscious sedation with dexmedetomidine or general anesthesia with desflurane, and surgeons use tiny recording electrodes to measure neuronal electrical activity during surgery. The main measure is the percentage of recordings that show high signal strength, measured as the average normalized root mean square over 2.0, and the study also compares signal size, length of the target area, number of recording tracks, and clinical outcomes at six months. The study enrolls people 50 to 80 years old having bilateral subthalamic nucleus deep brain stimulation who meet routine anesthesia fitness (ASA grade II to III), excluding those with sleep apnea, body mass index over 30, predicted difficult airway, severe preoperative anxiety, major organ failure, or allergy to the anesthetics.
Locations
- Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying general anesthesia. The trial is testing whether general anesthesia with desflurane changes the brain-mapping signals used during deep brain stimulation of a small area called the subthalamic nucleus, and whether any signal differences affect clinical results six months after surgery. Patients are randomly assigned to either conscious sedation with dexmedetomidine or general anesthesia with desflurane, and surgeons use tiny recording electrodes to measure neuronal electrical activity during surgery. The main measure is the percentage of recordings that show high signal strength, measured as the average normalized root mean square over 2.0, and the study also compares signal size, length of the target area, number of recording tracks, and clinical outcomes at six months. The study enrolls people 50 to 80 years old having bilateral subthalamic nucleus deep brain stimulation who meet routine anesthesia fitness (ASA grade II to III), excluding those with sleep apnea, body mass index over 30, predicted difficult airway, severe preoperative anxiety, major organ failure, or allergy to the anesthetics.
- Who can participate?
- Participants must be between 50 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 1 year and 5 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- 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.