- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04978246
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
Completed
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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İstanbul
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Beykoz, İstanbul, Turkey, 34810
- Istanbul Medipol University
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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:
|
|
Control Group
The control group consists of 50 healthy individuals aged 18-50 years who have not had COVID-19.
|
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:
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What is the study measuring?
Primary Outcome Measures
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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
|
Secondary Outcome Measures
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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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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.
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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Digit Span
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
|
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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Stroop Test
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
|
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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Rey-Osterrieth Complex Figure Test (ROCF)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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Neuropsychiatric Inventory (NPI)
Time Frame: Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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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.
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Any day between 21-60 days from the date of COVID-10 RT-PCR test positive.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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)
December 15, 2020
Primary Completion (Actual)
January 10, 2021
Study Completion (Actual)
July 30, 2021
Study Registration Dates
First Submitted
July 18, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 27, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurocognitive Disorders
- Infant, Newborn, Diseases
- Cognition Disorders
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Cognitive Dysfunction
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID 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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