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Cognitive ImpairmentNCT03946839

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

An observational study of Cognitive Impairment and Functional Magnetic Resonance Imaging, run by Jian-jun Yang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
How many people
40 participants
Where
1 siteChina
Study dates
1 Jun 2020to 20 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangyin People's Hospital

    Jiangyin, Jiangsu, 210009

Other trials in China

About this study

Official title: 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.

Read the 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.

Medical subject headings
Cognitive Dysfunction, Shock, Septic, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03946839
Study groupRoleWhat they receive
ICU Survivorssepsis/septic shock Patients with high risk of cognitive impairment who discharge from ICU
Healthy ControlThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1.5 h before fMRI examination

  2. 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.

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

  3. 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.

    Measured: 2h before taking fMRI examination

Secondary outcomes (10)

  1. Blood markers

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

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

  2. 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.

    Measured: 1.5h before taking fMRI examination

  3. 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.

    Measured: 1.5h before taking fMRI examination

  4. 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.

    Measured: 1.5h before taking fMRI examination

  5. 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.

    Measured: 1.5h before taking fMRI examination

  6. 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.

    Measured: 1.5h before taking fMRI examination

  7. 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.

    Measured: 1.5h before taking fMRI examination

  8. 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.

    Measured: 1.5h before taking fMRI examination

  9. 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.

    Measured: 1.5h before taking fMRI examination

  10. 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.

    Measured: 1.5h before taking fMRI examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2019
  2. Study start1 Jun 2020
  3. Primary completion20 Nov 2023
  4. Study completion20 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03946839
Sponsor's protocol ID
20190510
Status last verified
Feb 2024
First submitted
9 May 2019
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Most participants were reluctant to share their personal information with researchers outside this study.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Impairment and Functional Magnetic Resonance Imaging, run by Jian-jun Yang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief assessment of cognitive impairment (time frame: 1.5 h before fMRI examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03946839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

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