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

NCT06157008 | Recruiting

• 1 other identifier: evchen99525
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Disorders of Consciousness

Outcome Measures

Primary Outcomes (4)

• Characteristics of sleep in pDoC patients

  Characteristics of sleep in pDoC patients compared with healthy volunteers

  January 1, 2023 to January 1, 2024

• Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia

  January 1, 2023 to January 1, 2024

• 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

• Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation

  January 1, 2023 to January 1, 2024

Study Arms (2)

healthy volunteers

patients with prolonged disorders of consciousness

Drug: General Anesthetics

Interventions

General Anesthetics DRUG

General anesthetics used in spinal cord electrical stimulator insertion surgery

patients with prolonged disorders of consciousness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged 18-65, native Chinese
• No history of sleep apnea
• No history of insomnia
• Volunteer to participate in this study and obtain informed consent.
• Aged 18-65, native Chinese
• pDoC after acquired brain injury
• The spinal electric stimulator was implanted under general anesthesia
• Obtain informed consent.

You may not qualify if:

• 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
• Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
• Known or suspected to have serious heart, lung and kidney dysfunction
• Allergic history of sedative drugs
• Combined with other mental or nervous system diseases
• Other reasons are not suitable for this study.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Ruquan Han, M.D

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: December 5, 2023
• Study Start: January 11, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)