Actively Recruiting
Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography
Led by Beijing Tiantan Hospital · Updated on 2024-08-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying prolonged disorders of consciousness (pDoC) and brain activity using polysomnography (PSG) in both healthy volunteers and patients with pDoC. This observational study aims to compare sleep patterns and brain network changes between these groups, as well as to analyze changes before and after spinal cord electrical stimulator insertion under general anesthesia. The study explores how anesthesia and spinal cord stimulation affect brain networks in patients with consciousness disorders. The study involves recording 8-hour sleep studies (PSG) in healthy volunteers and multiple PSG recordings in patients with pDoC: before and 24 hours after spinal cord stimulator implantation surgery, and a 24-hour recording after starting spinal cord stimulation. The surgery includes the use of general anesthetics. The study monitors brain network characteristics related to anesthesia and spinal cord stimulation effects. Participants will undergo PSG recordings and brain activity assessments at specified times related to surgery and stimulation. The research team will evaluate sleep characteristics, brain networks during sleep EEG, and consciousness recovery at 30, 90, and 180 days after surgery. Data collection focuses on understanding brain function changes in pDoC patients, supported by follow-up assessments to monitor recovery over time. Participation duration varies per individual, with close observation during and after interventions.
CONDITIONS
Brief Title
Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18-65, native Chinese speakers
- Healthy volunteers with no history of sleep apnea
- Healthy volunteers with no history of insomnia
- Healthy volunteers who volunteer and provide informed consent
- Patients aged 18-65, native Chinese speakers
- Patients with prolonged disorders of consciousness after acquired brain injury
- Patients undergoing spinal electric stimulator implantation under general anesthesia
- Patients who provide informed consent
You will not qualify if you...
- Healthy volunteers who took hypnotic drugs within 72 hours before the study
- Participants who received continuous sedation treatment within 72 hours before the study
- Participants with brain structure damage such as open head injury or brain tissue removal
- Participants with decreased intracranial compliance due to hydrocephalus
- Participants with airway narrowing or severe ventilation dysfunction
- Participants with known or suspected serious heart, lung, or kidney dysfunction
- Participants with allergic history to sedative drugs
- Participants with other mental or nervous system diseases
- Participants deemed unsuitable for the study for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive general anesthetics during spinal cord electrical stimulator insertion surgery.
1 visit (in-person)
Duration - Up to 180 days after surgery
Participants are monitored for consciousness recovery and sleep characteristics after surgery.
Visits at 30, 90, and 180 days after surgery
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
R
Ruquan Han, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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