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NCT Number: NCT06517706

Brain Research and Integrative Neuroscience Network for COVID-19

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.

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cyprus

Nicosia, Cyprus, 1678

Location status: Recruiting

Location contact

Fofi Constantinidou, Ph.D.

CONTACT

[email protected]

35722894437

Fofi Constantinidou, Ph.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Combination Product

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

Categorization Program

Behavioral

Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS

Primary outcomes

  1. Categorization Program Test 1

    Time frame: Administered pre & post training with the Categorization Program, at 6 weeks

    Semantic knowledge and classification behavior

  2. Categorization Program Test 2

    Time frame: Administered pre & post training with the Categorization Program, at 6 weeks

    Decision-Making and Rule based learning

  3. Probe Tasks

    Time frame: Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks

    Decision-Making and Rule based learning

  4. WHO BREF Quality of Life

    Time frame: before and after training, at 6 weeks

    general quality of life

  5. Dysexecutive Questionnaire

    Time frame: pre and post training, at 6 weeks

    Test of everyday executive functioning behaviors; self and informant reports

Other outcomes

  1. Cognitron Cognitive Assessment Battery

    Time frame: Pre & Post Testing, after completion of training at 6 weeks

    Tests of memory, reaction time, and executive Functioning

  2. fNIRS

    Time frame: pre and post training testing, after completion of training at 6 weeks

    Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses

Study contacts

Contact information is provided by the study sponsor or research team.

Eleni Michael

CONTACT

[email protected]

+35722895190

Fofi Constantinidou, Ph.D.

CONTACT

[email protected]

+357 22892078

Sponsors and collaborators

Lead sponsor

University of Cyprus

Other

Registry information

Official study title

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

Acronym: BRAINN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Dec 6, 2024

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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