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

Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography

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.

Study Overview

• Status: Recruiting
• Conditions: Disorders of Consciousness
• Intervention / Treatment: Drug: General Anesthetics

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital
    • Contact: Ruquan Han; Phone Number: 8610-59976660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers
patients with prolonged disorders of consciousness	Drug: General Anesthetics; General anesthetics used in spinal cord electrical stimulator insertion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of sleep in pDoC patients	Characteristics of sleep in pDoC patients compared with healthy volunteers	January 1, 2023 to January 1, 2024
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, General
• Other Study ID Numbers: evchen99525

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No