Brain Research and Integrative Neuroscience Network for COVID-19

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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
• Поведенческое Categorization Program
  Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS

Первичные конечные точки

• Categorization Program Test 1 [Срок оценки: Administered pre & post training with the Categorization Program, at 6 weeks]
• Categorization Program Test 2 [Срок оценки: Administered pre & post training with the Categorization Program, at 6 weeks]
• Probe Tasks [Срок оценки: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks]
• WHO BREF Quality of Life [Срок оценки: before and after training, at 6 weeks]
• Dysexecutive Questionnaire [Срок оценки: pre and post training, at 6 weeks]

Критерии участия

Критерии включения

• Reported cognitive difficulties due to COVID-19 infection
• WHO Long COVID criteria will be used

Критерии исключения

• Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Cyprus · 1 центр

• University of Cyprus — Nicosia

Идентификаторы

NCT: NCT06517706 · 101079001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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