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

Sponsor
Indonesia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05670418
Collaborator
(none)
45
1
8.9
5

Study Details

Study Description

Brief Summary

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 MMSE MOCA, mini ICD 10, and SF 36. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Quantitative Electroencephalography

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 MMSE MOCA questionnaire, mini ICD 10, and SF 36.

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 Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Cognitive Function [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

Secondary Outcome Measures

  1. Cognitive quality Assessed by MMSE MOCA [Through study completion, an average of 1 year]

    Severe score: ≤9 Moderate score: 10-22 Mild score: 23-26 Normal score: 27-30

  2. Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD-10) [Through study completion, an average of 1 year]

    Will be assessed whether the subject has a depressive episode (Yes/No)

  3. Health-Related Quality of Life Assessed by The 360-Item Short From Health Survey Questionnaire (SF-36) [Through study completion, an average of 1 year]

    Lowest score: 0 Highest score: 100 Higher score indicates better health status, and a mean score of 50 has been articulated as a normative value for all scales

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 MMSE MOCA, MINI ICD-10, and SF-36 assessment

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rumah Sakit Cipto Manunkusumo Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. dr Yetty Ramli SpS, Medical Staff & Lecturer, Indonesia University
ClinicalTrials.gov Identifier:
NCT05670418
Other Study ID Numbers:
  • 22-05-0578
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. dr Yetty Ramli SpS, Medical Staff & Lecturer, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023