COVID-19NCT05961618
Brain Function Changes Following COVID-19 Infection
An observational study of COVID-19, run by RenJi Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cortical Excitability and Neuropsychological Behavior Changes Following COVID-19 Infection in the Human Brain
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).
- Conditions
- COVID-19
- Keywords
- covid-19, TMS, response inhibition, decision-
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uninfected | Subjects who had recovered from SARS-CoV-2 infection | |
| Infected | Subjects who had not been infected with SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cortical excitability changes following COVID-19 infection.
This was assessed by single/paired pulse TMS procedures.
Measured: 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).
Measured: January 2023 to March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961618
- Sponsor's protocol ID
- LY2023-133
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Yang H, Wang C, Yuan TF, Zhang S. Reduced risk tolerance and cortical excitability following COVID-19 infection. CNS Neurosci Ther. 2024 Aug;30(8):e14879. doi: 10.1111/cns.14879. No abstract available.
PubMed 39107954
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability and Neuropsychological Behavior Changes Following COVID-19 Infection in the Human Brain
- ClinicalTrials.gov ID
- NCT05961618
- Acronym / sponsor ID
- LY2023-133
- Conditions
- COVID-19
- Keywords
- covid-19, TMS, response inhibition, decision-
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uninfected | – | –Subjects who had recovered from SARS-CoV-2 infection |
| Infected | – | –Subjects who had not been infected with SARS-CoV-2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cortical excitability changes following COVID-19 infection.
Time frame: January 2023 to March 2023
This was assessed by single/paired pulse TMS procedures.
1 secondary outcome
The neuropsychological behaviors following COVID-19 infection.
Time frame: January 2023 to March 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 39107954Wang Y, Yang H, Wang C, Yuan TF, Zhang S. Reduced risk tolerance and cortical excitability following COVID-19 infection. CNS Neurosci Ther. 2024 Aug;30(8):e14879. doi: 10.1111/cns.14879. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by RenJi Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liqun Yang, MD (+86-15921969001, lqyang72721@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cortical excitability changes following COVID-19 infection. (time frame: January 2023 to March 2023). 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 NCT05961618, which also lists 1 linked publication.
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 27 Jul 2023.