Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients

November 17, 2023 updated by: Dr. dr Yetty Ramli SpS, Indonesia University

Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. This condition has ties to decreased cognitive function and may lead to neuropsychiatric disorders but still need to be studied further. Using a cross-sectional design, this study will analyze the relationship between cognitive function and neuropsychiatric disorders with brain wave activity in Long COVID patients.

The investigators conducted assessments utilizing the quantitative electroencephalogram (qEEG) measurement method and interviews using instruments such as the MOCA questionnaire and Self Rating Questionnaire (SRQ). With this qEEG examination, the investigators hoped that there will be an imbalance/abnormality of brain wave activity that arises related to impaired cognitive function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is aimed to analyze the cognitive function and neuropsychiatry disorders with brain wave activity using qEEG that occurs after COVID/Long Covid Syndrome.

The whole procedure will run for approximately 12 weeks based on the long COVID range.

The determinants of long COVID patients include: never been vaccinated, old age, comorbid, female population, and hospitalized patients.

The total number of subjects with the post-COVID syndrome in the proportion test is 30 subjects.

The measuring instruments used to measure the decline in cognitive function are the MOCA questionnaire and Self Rating Questionnaire (SRQ).

The target population is post-COVID-19 patients with Long COVID Syndrome.

The accessible population is post-COVID-19 patients who have been treated at RSCM Kiara and have regular checkups at the RSCM polyclinic with Long COVID Syndrome for 12 weeks or more.

The control population is post-COVID-19 patients who managed to recover without symptoms.

The Long COVID Syndrome patients who meet the inclusion criteria and have signed the consent.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Rumah Sakit Cipto Manunkusumo
        • Contact:
        • Principal Investigator:
          • Yetty Ramli, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COVID-19 Patients

Description

Inclusion Criteria:

  1. Post-COVID-19 patients with Long COVID-19 Syndrome
  2. Over 18 years old
  3. Willing to participate in the research
  4. Completed the Montreal Cognitive Assessment (MoCA) and Self Rating Questionnaire (SRQ)

Exclusion Criteria:

1. Patients with neuropsychiatric disorders before being infected with COVID-19

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Long COVID-19
Patients post-COVID-19 with Long COVID-19 Syndrome
Device: Quantitative Electroencephalography
Each qEEG examination of one person lasted about 20 minutes and included two stages: the first-recording of brain waves with eyes closed (5 min), the other with eyes open (5 min)
COVID-19
Patients post-COVID-19 without Long COVID-19 Syndrome
Device: Quantitative Electroencephalography
Each qEEG examination of one person lasted about 20 minutes and included two stages: the first-recording of brain waves with eyes closed (5 min), the other with eyes open (5 min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: Through study completion, an average of 1 year
Cognitive Function will be assessed using the qEEG, with an abnormality of brain wave activity, it indicates impairment of cognitive function
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive quality Assessed by MOCA
Time Frame: Through study completion, an average of 1 year
Severe score: ≤10 Moderate score: 10-17 Mild score: 18-25 Normal score: 26-30
Through study completion, an average of 1 year
Self Rating Questionnaire (SRQ)
Time Frame: Through study completion, an average of 1 year
Lowest score: 0 Highest score: 20. Higher score indicates better health status.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Indonesia University

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)

October 1, 2022

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

January 1, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-05-0578

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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