Brain Network Analysis of Anesthesia Characteristics in P... | NCT06157008

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

NCT06157008

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Aug 1, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Disorders of Consciousness

Interventions

General Anesthetics

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2023Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Jan 12, 2023

First Submission Date that Met QC Criteria

Dec 3, 2023

First Posted Date

Dec 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
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.
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteers
patients with prolonged disorders of consciousness			Drug: General Anesthetics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
General Anesthetics	Drug	General anesthetics used in spinal cord electrical stimulator insertion surgery	patients with prolonged disorders of consciousness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ruquan Han, M.D	Contact	8610-59976660		ruquan.han@ccmu.edu.cn

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D003244	Consciousness Disorders

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018681	Anesthetics, General

Ancestor Terms

ID	Term
D000777	Anesthetics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided