Cognitive Functions After COVID-19

Cognitive Decline Clinical Trial

Official title:

Evaluation Of Cognitive Functions In Adult Individuals With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978246
• Other study ID #: Medipol Mega3
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Cognitive Decline
• Cognitive Dysfunction
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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).

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Beykoz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Zhou H, Lu S, Chen J, Wei N, Wang D, Lyu H, Shi C, Hu S. The landscape of cognitive function in recovered COVID-19 patients. J Psychiatr Res. 2020 Oct;129:98-102. doi: 10.1016/j.jpsychires.2020.06.022. Epub 2020 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment Test (MoCA)	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	Clock Drawing Test	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.
Secondary	Öktem Verbal Memory Processes Test (Ö-SBST)	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.
Secondary	Digit Span	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.
Secondary	Verbal Fluency Test	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.
Secondary	Stroop Test	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.
Secondary	Trail Making Test	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.
Secondary	Rey-Osterrieth Complex Figure Test (ROCF)	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.
Secondary	Neuropsychiatric Inventory (NPI)	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.