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NCT Number: NCT03946839

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

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Functional Magnetic Resonance Imaging Infections Inflammation Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangyin People's Hospital

Jiangyin, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Brief assessment of cognitive impairment

    Time frame: 1.5 h before fMRI examination

    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.

  2. Resting-state functional magnetic resonance imaging results

    Time frame: Up to 1 month after ICU discharge(It was judged by the doctor in charge according to the patient's recovery)

    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.

  3. Blood inflammatory markers

    Time frame: 2h before taking fMRI examination

    2-4 ml of blood was drawn for blood inflammatory markers(IL-1β,IL-2R,IL-6,IL-8,TNF-α) detection.

Secondary outcomes

  1. Blood markers

    Time frame: the same day with fMRI examination（2h before taking fMRI examination）

    2-4 ml of blood was drawn for blood markers(NSE) detection.

  2. Assessment of cognitive impairment

    Time frame: 1.5h before taking fMRI examination

    Cognitive impairment assessed with help of MoCA(Montreal Cognitive Assessment).Total score range from 0-30. Lower scores = more disability, higher scores = less disability.

  3. Specific assessment of cognitive impairment 1

    Time frame: 1.5h before taking fMRI examination

    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.

  4. Specific assessment of cognitive impairment 2

    Time frame: 1.5h before taking fMRI examination

    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.

  5. Specific assessment of cognitive impairment 3

    Time frame: 1.5h before taking fMRI examination

    Cognitive impairment assessed with help of CFT(complex figure test),Total score range from 0-36. Lower scores = more disability, higher scores = less disability.

  6. Specific assessment of cognitive impairment 4

    Time frame: 1.5h before taking fMRI examination

    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.

  7. Specific assessment of cognitive impairment 5

    Time frame: 1.5h before taking fMRI examination

    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.

  8. Specific assessment of cognitive impairment 6

    Time frame: 1.5h before taking fMRI examination

    Cognitive impairment assessed with help of CDT(clock drawing test),Total score range from 0-4. Lower scores = more disability, higher scores = less disability.

  9. Specific assessment of cognitive impairment 7

    Time frame: 1.5h before taking fMRI examination

    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.

  10. Assessment of Depression

    Time frame: 1.5h before taking fMRI examination

    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.

Sponsors and collaborators

Lead sponsor

Jian-jun Yang

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 13, 2019
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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