Brain Research and Integrative Neuroscience Network for COVID-19

Last updated: December 3, 2024
Sponsor: University of Cyprus
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Categorization Program

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

Clinical Study ID

NCT06517706
101079001
  • Ages 25-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Reported cognitive difficulties due to COVID-19 infection

  • WHO Long COVID criteria will be used

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Categorization Program
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Cyprus

    Nicosia, 1678
    Cyprus

    Active - Recruiting

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