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NCT Number: NCT06157008

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

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.

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Key information

Conditions

Disorders of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, China

Location status: Recruiting

Location contact

Ruquan Han

CONTACT

8610-59976660

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria of health volunteer group:
  • Aged 18-65, native Chinese
  • No history of sleep apnea
  • No history of insomnia
  • Volunteer to participate in this study and obtain informed consent.
  • Inclusion criteria of pDoC group:
  • Aged 18-65, native Chinese
  • pDoC after acquired brain injury
  • The spinal electric stimulator was implanted under general anesthesia
  • Obtain informed consent.
  • Exclusion Criteria:
  • Healthy volunteers took hypnotic drugs 72 hours before the study
  • Continuous sedation treatment was carried out within 72 hours before the study
  • The integrity of brain structures such as open head injury and brain parenchyma resection
  • Intracranial compliance decreased due to hydrocephalus
  • Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
  • Known or suspected to have serious heart, lung and kidney dysfunction
  • Allergic history of sedative drugs
  • Combined with other mental or nervous system diseases
  • Other reasons are not suitable for this study.

Treatment and study plan

General Anesthetics

Drug

General anesthetics used in spinal cord electrical stimulator insertion surgery

Primary outcomes

  1. Characteristics of sleep in pDoC patients

    Time frame: January 1, 2023 to January 1, 2024

    Characteristics of sleep in pDoC patients compared with healthy volunteers

  2. Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia

    Time frame: January 1, 2023 to January 1, 2024

  3. Sleep electroencephalogram and characteristic brain network of pDoC patients before and after starting the spinal cord electric stimulator

    Time frame: January 1, 2023 to January 1, 2024

  4. Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation

    Time frame: January 1, 2023 to January 1, 2024

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, M.D

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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