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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Aged 18-65, native Chinese

No history of sleep apnea

No history of insomnia

Volunteer to participate in this study and obtain informed consent.

Disqualifiers

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

Trial population

The people with prolonged disorders of consciousness who will be implanted with spinal cord electric stimulator under general anesthesia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • General Anesthetics

    Drug

    General anesthetics used in spinal cord electrical stimulator insertion surgery

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: healthy volunteers0 interventions
Group B: patients with prolonged disorders of consciousness1 intervention

Trial outcomes

Primary outcomes

1

Characteristics of sleep in pDoC patients

Characteristics of sleep in pDoC patients compared with healthy volunteers

Time frame
January 1, 2023 to January 1, 2024
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

Secondary outcomes

Other outcomes

Sponsors and contacts

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