Brain Research and Integrative Neuroscience Network for COVID-19
NCT ID: NCT06517706
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-11-15
2025-12-31
Brief Summary
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Detailed Description
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Changes in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board. The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment. Specifically, the feasibility study will retain the two-group design (experimental and control). Forty participants with PCS will be recruited (instead of seventy, as originally planned). All participants will undergo the diagnostic protocols (the neuroimaging and neuropsychological assessments). Then, participants will be randomly assigned into two groups: the experimental, who will receive the active tDCS and CP intervention, and the control group, who will receive the sham tDCS and CP intervention. Following the intervention, all participants (experimental and control) will complete a series of dependent measures, including neuropsychological performance and quality of life measures. For neurophysiological measures, electroencephalography (EEG) has been replaced with functional near-infrared spectroscopy (fNIRS), which will be conducted both pre- and post-intervention. The current design will require a longer intervention period (as compared to the original design) and the complete delivery of the digitalized CP to maximize treatment effectiveness.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Control Condition
Combination of cognitive training with sham tDCS
Categorization Program
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Experimental Condition
Combination of cognitive training with active tDCS
Combination of tDCS (device) with cognitive training (behavioral)
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program
Interventions
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Combination of tDCS (device) with cognitive training (behavioral)
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program
Categorization Program
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Eligibility Criteria
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Inclusion Criteria
* WHO Long COVID criteria will be used
Exclusion Criteria
25 Years
60 Years
FEMALE
No
Sponsors
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University of Cyprus
OTHER
Responsible Party
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Fofi Constantinidou
Professor of Psychology
Principal Investigators
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Fofi Constantinidou, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Cyprus
Locations
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University of Cyprus
Nicosia, Cyprus, Cyprus
Countries
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Central Contacts
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Facility Contacts
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Fofi Constantinidou, Ph.D.
Role: primary
Fofi Constantinidou, Ph.D.
Role: backup
Related Links
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Project website
Other Identifiers
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101079001
Identifier Type: -
Identifier Source: org_study_id