University of Cyprus
Nicosia, Cyprus, 1678
Location status: Recruiting
NCT Number: NCT06517706
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.
Interested in participating?
Request Info25 year–60 year
Female
Interventional
Not applicable
Nicosia, Cyprus, 1678
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Time frame: Administered pre & post training with the Categorization Program, at 6 weeks
Semantic knowledge and classification behavior
Time frame: Administered pre & post training with the Categorization Program, at 6 weeks
Decision-Making and Rule based learning
Time frame: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks
Decision-Making and Rule based learning
Time frame: before and after training, at 6 weeks
general quality of life
Time frame: pre and post training, at 6 weeks
Test of everyday executive functioning behaviors; self and informant reports
Time frame: Pre & Post Testing, after completion of training at 6 weeks
Tests of memory, reaction time, and executive Functioning
Time frame: pre and post training testing, after completion of training at 6 weeks
Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses
Contact information is provided by the study sponsor or research team.
Eleni Michael
CONTACT
Fofi Constantinidou, Ph.D.
CONTACT
University of Cyprus
Other
Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)
Acronym: BRAINN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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