Brain Research and Integrative Neuroscience Network for COVID-19
- Conditions
- Transcranial Direct Current StimulationCognitive Training
- Interventions
- Behavioral: Categorization ProgramCombination Product: Combination of tDCS (device) with cognitive training (behavioral)
- Registration Number
- NCT06517706
- Lead Sponsor
- University of Cyprus
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
- Reported cognitive difficulties due to COVID-19 infection
- WHO Long COVID criteria will be used
- Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control Condition Categorization Program Combination of cognitive training with sham tDCS Experimental Condition Combination of tDCS (device) with cognitive training (behavioral) Combination of cognitive training with active tDCS
- Primary Outcome Measures
Name Time Method Categorization Program Test 2 Administered pre & post training with the Categorization Program, at 6 weeks Decision-Making and Rule based learning
Dysexecutive Questionnaire pre and post training, at 6 weeks Test of everyday executive functioning behaviors; self and informant reports
Probe Tasks Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks Decision-Making and Rule based learning
Categorization Program Test 1 Administered pre & post training with the Categorization Program, at 6 weeks Semantic knowledge and classification behavior
WHO BREF Quality of Life before and after training, at 6 weeks general quality of life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Cyprus
🇨🇾Nicosia, Cyprus