Brain Research and Integrative Neuroscience Network for COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination of tDCS (device) with cognitive training (behavioral), Categorization Program.
- Who it may be relevant to
- Registry conditions: Cognitive Training, Transcranial Direct Current Stimulation. Basic parameters: 25 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Cyprus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)
Overview
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 product Combination of tDCS (device) with cognitive training (behavioral)
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 - Behavioral Categorization Program
Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Primary outcome measures
- Categorization Program Test 1 [Time frame: Administered pre & post training with the Categorization Program, at 6 weeks]
- Categorization Program Test 2 [Time frame: Administered pre & post training with the Categorization Program, at 6 weeks]
- Probe Tasks [Time frame: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks]
- WHO BREF Quality of Life [Time frame: before and after training, at 6 weeks]
- Dysexecutive Questionnaire [Time frame: pre and post training, at 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Cyprus · 1 center
- University of Cyprus — Nicosia
Identifiers
NCT: NCT06517706 · 101079001