Clinical trial NCT06157008: Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG
Official title: Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disorders of Consciousness
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The people with prolonged disorders of consciousness who will be implanted with spinal cord electric stimulator under general anesthesia.

Brief summary: The goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pDoC). The main questions it aims to answer are:

1. Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
2. To observe the similarities and differences of polysomnography in pDoC patients before and after Insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography.
3. To observe the similarities and differences of polysomnography in pDoC patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation.

We will record the 8h polysomnography of healthy volunteers,record the polysomnography of DOC patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria of health volunteer group:

  1. Aged 18-65, native Chinese
  2. No history of sleep apnea
  3. No history of insomnia
  4. Volunteer to participate in this study and obtain informed consent.
* Inclusion criteria of pDoC group:

  1. Aged 18-65, native Chinese
  2. pDoC after acquired brain injury
  3. The spinal electric stimulator was implanted under general anesthesia
  4. Obtain informed consent.
* Exclusion Criteria:

  1. Healthy volunteers took hypnotic drugs 72 hours before the study
  2. Continuous sedation treatment was carried out within 72 hours before the study
  3. The integrity of brain structures such as open head injury and brain parenchyma resection
  4. Intracranial compliance decreased due to hydrocephalus
  5. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
  6. Known or suspected to have serious heart, lung and kidney dysfunction
  7. Allergic history of sedative drugs
  8. Combined with other mental or nervous system diseases
  9. Other reasons are not suitable for this study.

Primary outcomes:
measure: Characteristics of sleep in pDoC patients
timeFrame: January 1, 2023 to January 1, 2024
measure: Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia
timeFrame: January 1, 2023 to January 1, 2024
measure: Sleep electroencephalogram and characteristic brain network of pDoC patients before and after starting the spinal cord electric stimulator
timeFrame: January 1, 2023 to January 1, 2024
measure: Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation
timeFrame: January 1, 2023 to January 1, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: