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The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID. Participants will be randomly assigned into two interventions. 1. Categorization Program (CP) training with active tDCS or 2. Categorization Program training with sham tDCS.
The two intervention protocols (digitalized CP and NIBS) required for this study have been developed and the required equipment (one existing and three new tDCS devices) has been acquired. Recruitment for the feasibility study is planned to begin in month 18, i.e., June 2024.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Condition | Sham Comparator | Combination of cognitive training with sham tDCS |
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| Experimental Condition | Experimental | Combination of cognitive training with active tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of tDCS (device) with cognitive training (behavioral) | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Categorization Program Test 1 | Semantic knowledge and classification behavior | Administered pre & post training with the Categorization Program, at 6 weeks |
| Categorization Program Test 2 | Decision-Making and Rule based learning | Administered pre & post training with the Categorization Program, at 6 weeks |
| Probe Tasks | Decision-Making and Rule based learning | Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks |
| WHO BREF Quality of Life | general quality of life | before and after training, at 6 weeks |
| Dysexecutive Questionnaire | Test of everyday executive functioning behaviors; self and informant reports | pre and post training, at 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitron Cognitive Assessment Battery | Tests of memory, reaction time, and executive Functioning | Pre & Post Testing, after completion of training at 6 weeks |
| fNIRS | Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fofi Constantinidou, Ph.D. | Contact | +357 22892078 | fofic@ucy.ac.cy | |
| Eleni Michael | Contact | +35722895190 | can@ucy.ac.cy |
| Name | Affiliation | Role |
|---|---|---|
| Fofi Constantinidou, Ph.D. | University of Cyprus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cyprus | Recruiting | Nicosia | Cyprus | 1678 | Cyprus |
Anonymized data will be entered in an open access depository as per funding agency's requirements. IPD that underlie results in a publication
After data has been published, December 2026.
upon request
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Random Assignment
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Participants will be randomly assigned to the experimental and control group. Both groups will receive cognitive rehabilitation. The experimental group control group will also active tDCS treatment whereas the control will receive inactive or sham tDCS treatment
|
| Categorization Program | Behavioral | Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS |
|
| pre and post training testing, after completion of training at 6 weeks |