Cognitive Functions After COVID-19

August 3, 2022 updated by: Büşra Tüfekçi, Medipol University

Evaluation Of Cognitive Functions In Adult Individuals With COVID-19

This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in the study. Cognitive functions of individuals with COVID19 compared with healthy individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. Fifty COVID-19 patients, aged between 18-50 years, who had positive RT-PCR test in the last 60 days and later recovered, were included in the study. The study group was compared with the control group consisting of 50 healthy individuals in whom gender, age and education year has not difference significantly. Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI). The study group was evaluated between 21 and 60 days from the onset of the disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Beykoz, İstanbul, Turkey, 34810
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • Having positive for the COVID-19 RT-PCR test and turned negative in the last 60 days.
  • be 18-50 years old
  • 21 days have passed since the onset of the disease

Exclusion Criteria:

  • Having any neurological or psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
The study group consists of 50 individuals aged 18-50 years who have received a positive COVID-19 RT-PCR test in the past 60 days.
Behavioral: Neuropsychometric Test
Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
Other Names:
  • Stroop Test
  • Montreal Cognitive Assessment Test (MoCA)
  • Clock Drawing Test
  • Öktem Verbal Memory Processes Test (Ö-SBST)
  • Digit Span Forward Test
  • Digit Span Backwards Test
  • Categorical Fluency
  • Phonemic Fluency
  • Trail Making Test A
  • Trail Making Test B
  • Rey-Osterrieth Complex Figure Test (ROCF)
  • Neuropsychiatric Inventory (NPI)
Control Group
The control group consists of 50 healthy individuals aged 18-50 years who have not had COVID-19.
Behavioral: Neuropsychometric Test
Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
Other Names:
  • Stroop Test
  • Montreal Cognitive Assessment Test (MoCA)
  • Clock Drawing Test
  • Öktem Verbal Memory Processes Test (Ö-SBST)
  • Digit Span Forward Test
  • Digit Span Backwards Test
  • Categorical Fluency
  • Phonemic Fluency
  • Trail Making Test A
  • Trail Making Test B
  • Rey-Osterrieth Complex Figure Test (ROCF)
  • Neuropsychiatric Inventory (NPI)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment Test (MoCA)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
It is a test that measures attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills in order to distinguish individuals with mild cognitive impairment from healthy individuals.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clock Drawing Test
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The person is asked to draw a clock circle and place numbers in it. After succeeding, they are asked to show 11 by 10 crossing. This test can test comprehension, memory, visuospatial functions and executive functions.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Öktem Verbal Memory Processes Test (Ö-SBST)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The test consists of fifteen unrelated words. Fifteen words are read to the subject at one-second intervals and then asked to say the ones that come to mind. In this process, information is collected about the subject's ability to maintain instant memory and attention. The number of correct answers of the subject is recorded as Instant Memory Score. After the first attempt, the same list is read to the subject nine more times, and each time he is asked to say all he remembers. This gives information about the subject's learning ability.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Digit Span
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The test consists of two parts as forward and backward span. In the forward digit span, the numbers are read at one second intervals and the patient is asked to repeat the randomly read numbers in the same order. It assesses attention and short-term memory. In the back digit span, it is requested to repeat the numbers read from the end to the beginning. Working memory is evaluated in the back count range. As the person succeeds in the trials, the test is continued by increasing one step. If the patient fails twice in a row for both sections, the test is discontinued.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Verbal Fluency Test
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Verbal fluency tests aim to evaluate the executive aspects of verbal behavior by using language capacity as a fluent speech. Verbal fluency tests are applied in two ways: phonemic fluency and semantic fluency. In the semantic fluency test, the person is asked to count animal names in one minute, and in the phonemic fluency test, the person is asked to produce words that start with a certain letter (K-A-S) and are not proper nouns.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Stroop Test
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The Stroop test evaluates focused attention, the ability to change attention in line with changing demands and under a distraction, the ability to suppress a habitual behavior pattern and perform an unusual behavior.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Trail Making Test
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The trail making test consists of two parts, A and B. In part A, the participants are asked to combine the circles with the numbers in the correct order and following each other (1-2-3-4-5...). In section B, there are letters and numbers placed in circles. Participants are asked to combine letters and numbers in the correct sequence (1-A-2-B-3-C-4-D...). The times of both sections are recorded. The A part of the IST evaluates the processing speed based on visual scanning ability, and the B part evaluates the complex attention, planning, set changing, blocking ability and following the sequentiality.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Rey-Osterrieth Complex Figure Test (ROCF)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The purpose of the test is to evaluate visuospatial structuring skills and visual memory. The test material consists of a complex shape printed on a card, a registration form, an identification form with 24 details, three blank sheets of paper, a pencil and an eraser. The subject is first asked to copy the complex shape and the copying time is noted. During copying, the subject is not informed that he will draw the shape again. In the next step, the complex shape is removed and the person is asked to draw the shape again as far as he can remember, and the drawing time is noted. This is instant recall application. After the instant recall, the subject is not informed that he will draw the shape again, and the subject's mind is occupied by introducing different tests. After 30 minutes, he is asked to draw again. This is the delayed recall phase.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
Neuropsychiatric Inventory (NPI)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
The scale is scored by interview with the patient's relative. A total of 12 behavioral domains (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy, disinhibition, irritability/lability, abnormal motor behavior, sleep/night behaviors, appetite and eating changes) are questioned.
Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Büşra Tüfekçi, MD, Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Medipol Mega3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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