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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Septic Shock; Cognitive Impairment; Functional Magnetic Resonance Imaging

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Jian-jun Yang, PhD; Phone Number: 13357739238; Email: yjyangjj@126.com
• Study Contact Backup: Name: Ying Li, MD; Phone Number: 15852655431; Email: shushao@yeah.net

Study Locations

• China
  • Jiangsu
    • Jiangyin, Jiangsu, China, 210009
      • Jiangyin People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

ICU sepsis/septic shock Survivors of Jiangyin people's Hospital and healthy people from community recruitment

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ICU Survivors; sepsis/septic shock Patients with high risk of cognitive impairment who discharge from ICU
Healthy Control; The control group have to be medically and cognitively healthy. These individuals are recruited from the community and all attempts will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Blood inflammatory markers	2-4 ml of blood was drawn for blood inflammatory markers(IL-1β,IL-2R,IL-6,IL-8,TNF-α) detection.	2h before taking fMRI examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jian-jun Yang
• Investigators: Principal Investigator: Mu huo Ji, PhD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Neurocognitive Disorders; Shock; Sepsis; Cognition Disorders; Inflammation; Shock, Septic; Cognitive Dysfunction
• Other Study ID Numbers: 20190510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Most participants were reluctant to share their personal information with researchers outside this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No