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

Disorders of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157008
• Other study ID #: evchen99525
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of sleep in pDoC patients	Characteristics of sleep in pDoC patients compared with healthy volunteers	January 1, 2023 to January 1, 2024
Primary	Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia		January 1, 2023 to January 1, 2024
Primary	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
Primary	Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation		January 1, 2023 to January 1, 2024