Functional Magnetic Resonance Imaging (fMRI) of Brain in ICU Survivors With Cognitive Impairment

Inflammation Clinical Trial

Official title:

Mechanism of Cognitive Impairment in ICU Sepsis/Septic Shock Survivors :a Study Using Resting-stage fMRI Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946839
• Other study ID #: 20190510
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: January 20, 2024

Study information

• Verified date: February 2024
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Long-term cognitive dysfunction greatly influences patient's quality of life after critical illness. However,its neurophysiological basis remains unknown.This is a 3 year fMRI study conducted at the Jiangyin people's Hospital. This study utilize resting-state functional magnetic resonance imaging(fMRI) to investigate the regional alterations in survivors with cognitive impairment.Further, the investigators hypothesize that these regional changes in fMRI activity are predictive of cognitive impairment.

Description:

Critically ill patients who had hospitalized in ICU at least 2 days and who consented to participate will take the examination of brain fMRI,blood inflammatory markers and cognitive assessment after ICU discharge. Individuals of healthy control group are recruited from the community will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors.Those healthy people will also take the examination of brain fMRI,blood inflammatory markers and cognitive assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 20, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

ICU sepsis/septic shock Survivors

• Men and women older than 18;education years=6(could speak, read, and write);Hospitalized in the ICU more than 2 days and already discharge from ICU;

Exclusion Criteria:

• MRI incompatibility;History of neurological disease(diagnosis of depression, schizophrenia, epilepsy, Parkinson's disease, Alzheimer's disease, demyelinating disease, cerebrovascular disease,etc);Severe brain injury;History of alcohol and drug addiction;use of psychotropic medications such as sleeping pills, selective serotonin reuptake inhibitors,etc.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Functional Magnetic Resonance Imaging
• Inflammation
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
China	Jiangyin People's Hospital	Jiangyin	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jian-jun Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief assessment of cognitive impairment	Cognitive impairment assessed with help of MMSE(Mini-mental State Examination).The MMSE has 5 scaled scores; the scores are weighted sums of the questions in each section. The 5 sections and their range of score are listed below:Orientation 0-10;Registration 0-3;Attention and calculation 0-5;Recall 0-3;Language 0-9.Total score range from 0-30. Lower scores = more disability, higher scores = less disability.	1.5 h before fMRI examination
Primary	Resting-state functional magnetic resonance imaging results	3D T1-weighted magnetization parameters: TR/TE/flip angle = 7.2 ms/min full/8; FOV = 256 mm; 312 slices; slice thickness = 1 mm.; For the BOLD sequence, a series of 35 interleaved transversal slices were acquired for full-brain coverage with a gradient-echo based, echo planar imaging (EPI) sequence with the following parameters: TR/TE/ flip angle = 2000 ms/30 ms/90; FOV = 224 mm; slice thickness = 4.0 mm.	Up to 1 month after ICU discharge(It was judged by the doctor in charge according to the patient's recovery)
Primary	Blood inflammatory markers	2-4 ml of blood was drawn for blood inflammatory markers(IL-1ß,IL-2R,IL-6,IL-8,TNF-a) detection.	2h before taking fMRI examination
Secondary	Blood markers	2-4 ml of blood was drawn for blood markers(NSE) detection.	the same day with fMRI examination(2h before taking fMRI examination)
Secondary	Assessment of cognitive impairment	Cognitive impairment assessed with help of MoCA(Montreal Cognitive Assessment).Total score range from 0-30. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 1	Cognitive impairment assessed with help of DS(digit span test),including DST-F(Forward digit span test) and DST-B(backward digit span test).Total score range from 5-20. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 2	Cognitive impairment assessed with help of AVLT(auditory verbal learning test),Total score range from 0-12. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 3	Cognitive impairment assessed with help of CFT(complex figure test),Total score range from 0-36. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 4	Cognitive impairment assessed with help of SDMT(symbol digit modalities test),Total score range from 0-105. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 5	Cognitive impairment assessed with help of VFT(verbal fluency test),The total score was the number of animals named in one minute. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 6	Cognitive impairment assessed with help of CDT(clock drawing test),Total score range from 0-4. Lower scores = more disability, higher scores = less disability.	1.5h before taking fMRI examination
Secondary	Specific assessment of cognitive impairment 7	Cognitive impairment assessed with help of TMT-A(trail making test part A) and TMT-B(trail making test part B), the test outcome was the time to complete the test(seconds). Longer time = more disability, Shorter time = less disability.	1.5h before taking fMRI examination
Secondary	Assessment of Depression	SDS(self-rating depression scale) was used to assess the depression status of the participants in the past week.The SDS has 20 questions; each question was scored on a scale of 1-4;total score range from 20-80;the standard score(total score multiplied by 1.25):less than 53 was normal group,53-62 was mild depression, 63-72 was moderate depression, more than 72 was severe depression.	1.5h before taking fMRI examination