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Not yet recruitingNCT05961618Updated Jul 27, 2023

Brain Function Changes Following COVID-19 Infection

An observational study in COVID-19, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The global COVID-19 pandemic has now led to millions of infections worldwide. It produces long-lasting changes in the general physiology of multiple organs, including the brain. Thus, this study aimed to comprehensively understand the cortical excitability and neuropsychological behavior changes in patients following SARS-CoV-2.

Read the detailed description

The global COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to millions of infections and deaths worldwide. However, many issues about the nature of some long-term infection-related symptoms have not yet been well clarified.

Several lines of evidence have shown that SARS-CoV-2 can attack multiple organs such as the lungs, heart, kidneys, liver, as well as brain. The pathophysiologic analyses have shown the impact of SARS-CoV-2 on the brain, including the virus-induced neuroinflammation, the immune reactions, and the possible presence of the coronavirus in the central nervous system in the COVID-19 cases. Indeed, patients who recovered from COVID-19 may experience several long-term symptoms related to brain health, such as fatigue, cognitive and attention deficits, anxiety, and depression, which can affect their ability to work or even daily life. Therefore, the neuropsychological behavior changes in patients following SARS-CoV-2 infection remain an ongoing study area.

In parallel, studies have shown that behavioral abnormities in COVID-19 patients are often accompanied by cortical changes. Utilizing magnetic resonance imaging, a more significant reduction in grey matter thickness and tissue contrast in the orbitofrontal cortex and parahippocampal gyrus has been identified. Other studies confirmed impairment of frontoparietal cognitive functions and frontoparietal hypometabolism by 18F-fluoro-2-deoxy-d-glucose positron emission tomography15. In addition, electroencephalogram abnormalities were also seen in patients who survived from COVID-19. In recent decades, transcranial magnetic stimulation (TMS) has been recognized as a promising and noninvasive adjuvant diagnostic tool enabling assessment of the excitatory and inhibitory properties of the motor cortex as well as brain connectivity17,18. However, the evidence of inhibitory or excitatory changes of intracortical networks in patients recovered from COVID-19 is still scarce.

In this study, we aimed to investigate whether deficits in response inhibition and decision-making could be found in patients following mild SARS-CoV-2 infection. Moreover, we also focused on the neurophysiological evaluation of excitability and neurotransmission within the primary motor cortex (M1).

02

Conditions studied

  • COVID-19

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Keywords

  • covid-19
  • TMS
  • response inhibition
  • decision-
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 48 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The medical record of subjects who received cognitive function and TMS tests between January 2023 and March 2023 by our investigation group were retrospectively analyzed.

Inclusion criteria

    1. Age between 18 and 60 years; 2. Completed the TMS and cognitive function tests; 3. Without physical discomfort or special physiological conditions (e.g., female subjects in their menstrual cycle or ovulation)

Exclusion criteria

Exclusion Criteria:

    1. Had previous history of neurological or psychiatric disorders; 2. Had cognitive impairment or use of recreational or therapeutic psychoactive drugs within the past three months;3. Had severe hepatic or renal impairment.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48 participants (estimated)
Patient registry
No

Groups and cohorts

  • Uninfected

    Subjects who had recovered from SARS-CoV-2 infection

  • Infected

    Subjects who had not been infected with SARS-CoV-2.

06

What researchers measure

Primary outcomes

  1. The cortical excitability changes following COVID-19 infection.

    This was assessed by single/paired pulse TMS procedures.

    Time frame: January 2023 to March 2023

Secondary outcomes

  1. The neuropsychological behaviors following COVID-19 infection.

    These were assessed by Stop-signal task (SST) and Choice under risk and ambiguity task (CRA).

    Time frame: January 2023 to March 2023

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05961618
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Jul 2023 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Jul 27, 2023

Study contacts

Liqun Yang, MD
Contact
lqyang72721@126.com
+86-15921969001

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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