Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)

University of Cyprus

Status: Enrolling

Conditions: Cognitive Training; Transcranial Direct Current Stimulation

Treatments: Behavioral: Categorization Program; Combination Product: Combination of tDCS (device) with cognitive training (behavioral)

Study type: Interventional

Funder types: Other

Identifiers

NCT06517706

101079001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Control Condition

Sham Comparator group

Description:

Combination of cognitive training with sham tDCS

Treatment:

Behavioral: Categorization Program

Experimental Condition

Experimental group

Description:

Combination of cognitive training with active tDCS

Treatment:

Combination Product: Combination of tDCS (device) with cognitive training (behavioral)