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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06157008
Enrollment
60
Registered
2023-12-05
Start date
2023-01-11
Completion date
2025-06-01
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of Consciousness

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.

Interventions

General anesthetics used in spinal cord electrical stimulator insertion surgery

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operationJanuary 1, 2023 to January 1, 2024
Characteristics of sleep in pDoC patientsJanuary 1, 2023 to January 1, 2024Characteristics of sleep in pDoC patients compared with healthy volunteers
Sleep EEG and characteristic brain network in pDoC patients before and after anesthesiaJanuary 1, 2023 to January 1, 2024
Sleep electroencephalogram and characteristic brain network of pDoC patients before and after starting the spinal cord electric stimulatorJanuary 1, 2023 to January 1, 2024

Countries

China

Contacts

Primary ContactRuquan Han, M.D
ruquan.han@ccmu.edu.cn8610-59976660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026