Brain Research and Integrative Neuroscience Network for COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-60
SponsorUniversity of Cyprus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reported cognitive difficulties due to COVID-19 infection
WHO Long COVID criteria will be used
Disqualifiers
Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.
Trial design
Design model
Factorial
Treatments tested in this trial
Combination of tDCS (device) with cognitive training (behavioral)
Combination productParticipation 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
BehavioralParticipation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Control ConditionSham comparator 1 intervention
Group B: Experimental ConditionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Categorization Program Test 1
Semantic knowledge and classification behavior
Time frame
Administered pre & post training with the Categorization Program, at 6 weeks2
Categorization Program Test 2
Decision-Making and Rule based learning
Time frame
Administered pre & post training with the Categorization Program, at 6 weeks3
Probe Tasks
Decision-Making and Rule based learning
Time frame
Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks4
WHO BREF Quality of Life
general quality of life
Time frame
before and after training, at 6 weeksOther outcomes
1
Cognitron Cognitive Assessment Battery
Tests of memory, reaction time, and executive Functioning
Time frame
Pre & Post Testing, after completion of training at 6 weeks2
fNIRS
Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses
Time frame
pre and post training testing, after completion of training at 6 weeksSponsors and contacts
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Source ClinicalTrials.gov