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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06157008
Collaborator
(none)
60
1
16.7
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: General Anesthetics

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography
Actual Study Start Date :
Jan 11, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
healthy volunteers

patients with prolonged disorders of consciousness

Drug: General Anesthetics
General anesthetics used in spinal cord electrical stimulator insertion surgery

Outcome Measures

Primary Outcome Measures

  1. Characteristics of sleep in pDoC patients [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 [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 [January 1, 2023 to January 1, 2024]

  4. Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation [January 1, 2023 to January 1, 2024]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital Beijing China

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT06157008
Other Study ID Numbers:
  • evchen99525
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023