esketamine for Parkinson's (NCT06543563)
Preserve brain signals during surgery
- Trial ID
- NCT06543563
- Official Title
- Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease（ASPIRE）：A Randomized Controlled, Double-blind Study
- Goal
- Preserve brain signals during surgery
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 102 participants
- Conditions
- PD - Parkinson's Disease, Deep Brain Stimulation, Esketamine
- Interventions
- esketamine, normal Saline
Summary For Families
They're testing whether adding esketamine to the usual sedative can help keep the tiny brain electrical signals used to guide subthalamic nucleus deep brain stimulation intact and whether it affects sleep, mood, delirium, or other side effects after surgery. Patients will be randomly assigned to receive either dexmedetomidine alone or dexmedetomidine plus esketamine during awake sedation, because research suggests esketamine can provide sedation and pain relief while preserving those active brain signals and may improve sleep and mood. The team will compare the strength and patterns of the microelectrode recordings using a standard measure called normalized root mean square, plus look at certain brain wave patterns, postoperative delirium, changes in sleep, anxiety and depression, and any adverse events. Adults aged 50 to 80 who are scheduled for bilateral subthalamic nucleus deep brain stimulation can join, with common exclusions like severe 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, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying esketamine. They're testing whether adding esketamine to the usual sedative can help keep the tiny brain electrical signals used to guide subthalamic nucleus deep brain stimulation intact and whether it affects sleep, mood, delirium, or other side effects after surgery. Patients will be randomly assigned to receive either dexmedetomidine alone or dexmedetomidine plus esketamine during awake sedation, because research suggests esketamine can provide sedation and pain relief while preserving those active brain signals and may improve sleep and mood. The team will compare the strength and patterns of the microelectrode recordings using a standard measure called normalized root mean square, plus look at certain brain wave patterns, postoperative delirium, changes in sleep, anxiety and depression, and any adverse events. Adults aged 50 to 80 who are scheduled for bilateral subthalamic nucleus deep brain stimulation can join, with common exclusions like severe 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?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Intravenous infusion (minimally invasive). Confirm the full schedule with the study coordinator.