Cognitive Training, Transcranial Direct Current Stimulation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTCombination of tDCS (device) with cognitive training (behavioral)
Participation in 15 one-hour sessions distributed over five weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program
BEHAVIORALCategorization Program
Participation in 15 one-hour sessions distributed over five weeks. During each session participants will receive cognitive training with the Categorization Program and sham tDCS
Sponsors
University of Cyprus
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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
Intervention model description
Random Assignment
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Reported cognitive difficulties due to COVID-19 infection * WHO Long COVID criteria will be used
Exclusion criteria
* Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Categorization Program Test 1 | Administered pre & post training with the Categorization Program, at 6 weeks | Semantic knowledge and classification behavior |
| Categorization Program Test 2 | Administered pre & post training with the Categorization Program, at 6 weeks | Decision-Making and Rule based learning |
| Probe Tasks | Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks | Decision-Making and Rule based learning |
| WHO BREF Quality of Life | before and after training, at 6 weeks | general quality of life |
| Dysexecutive Questionnaire | pre and post training, at 6 weeks | Test of everyday executive functioning behaviors; self and informant reports |
Countries
Cyprus
Contacts
PRINCIPAL_INVESTIGATORFofi Constantinidou, Ph.D.
University of Cyprus
Outcome results
None listed