Clinical trial NCT06517706: Brain Research and Integrative Neuroscience Network for COVID-19
Official title: Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Training
Transcranial Direct Current Stimulation
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Random Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Categorization Program Test 1
timeFrame: Administered pre & post training with the Categorization Program, at 6 weeks
measure: Categorization Program Test 2
timeFrame: Administered pre & post training with the Categorization Program, at 6 weeks
measure: Probe Tasks
timeFrame: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks
measure: WHO BREF Quality of Life
timeFrame: before and after training, at 6 weeks
measure: Dysexecutive Questionnaire
timeFrame: pre and post training, at 6 weeks
Secondary outcomes:
Other outcomes:
measure: Cognitron Cognitive Assessment Battery
timeFrame: Pre & Post Testing, after completion of training at 6 weeks
measure: fNIRS
timeFrame: pre and post training testing, after completion of training at 6 weeks
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
Study officials:
affiliation: University of Cyprus
name: Fofi Constantinidou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: