Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG

Recruiting

• Conditions: Disorders of Consciousness
• Interventions: Drug: General Anesthetics

• Registration Number: NCT06157008
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with prolonged disorders of consciousness	General Anesthetics	-

Primary Outcome Measures

Name	Time	Method
Characteristics of sleep in pDoC patients	January 1, 2023 to January 1, 2024	Characteristics of sleep in pDoC patients compared with healthy volunteers
Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia	January 1, 2023 to January 1, 2024
Sleep electroencephalogram and characteristic brain network of pDoC patients before and after starting the spinal cord electric stimulator	January 1, 2023 to January 1, 2024
Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation	January 1, 2023 to January 1, 2024

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China