Optimize electrode placement using esketamine
- 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
- Optimize electrode placement using esketamine
- 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
The goal is to find out whether using esketamine during microelectrode recording-guided subthalamic deep brain stimulation helps provide steady, safe sedation while keeping the brain signals surgeons use to place DBS leads accurate, which can improve surgery for Parkinson's motor symptoms. Esketamine is a fast-acting anesthetic that blocks NMDA receptors to give sedation and pain relief, it affects brain activity differently than levodopa which works on dopamine so it is used only during surgery rather than as a Parkinson's treatment, and the team will watch for blood pressure changes or brief hallucinatory effects during the operation. Eligible participants are adults 50 to 80 years old scheduled for bilateral STN-DBS with ASA grade II or III, and people with sleep apnea, BMI over 30, difficult airways, severe anxiety, major organ failure, or anesthesia allergies are excluded.
Locations
- Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying esketamine. The goal is to find out whether using esketamine during microelectrode recording-guided subthalamic deep brain stimulation helps provide steady, safe sedation while keeping the brain signals surgeons use to place DBS leads accurate, which can improve surgery for Parkinson's motor symptoms. Esketamine is a fast-acting anesthetic that blocks NMDA receptors to give sedation and pain relief, it affects brain activity differently than levodopa which works on dopamine so it is used only during surgery rather than as a Parkinson's treatment, and the team will watch for blood pressure changes or brief hallucinatory effects during the operation. Eligible participants are adults 50 to 80 years old scheduled for bilateral STN-DBS with ASA grade II or III, and people with sleep apnea, BMI over 30, difficult airways, severe anxiety, major organ failure, or anesthesia allergies are excluded.
- 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?
- 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 1 year and 5 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.