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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-11

Study Completion Date

2025-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Disorders of Consciousness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy volunteers

No interventions assigned to this group

patients with prolonged disorders of consciousness

General Anesthetics

Intervention Type DRUG

General anesthetics used in spinal cord electrical stimulator insertion surgery

Interventions

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General Anesthetics

General anesthetics used in spinal cord electrical stimulator insertion surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes