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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Training; Transcranial Direct Current Stimulation
• Intervention / Treatment: Behavioral: Categorization Program; Combination product: Combination of tDCS (device) with cognitive training (behavioral)

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fofi Constantinidou, Ph.D.; Phone Number: +357 22892078; Email: fofic@ucy.ac.cy
• Study Contact Backup: Name: Eleni Michael; Phone Number: +35722895190; Email: can@ucy.ac.cy

Study Locations

• Cyprus
  • Nicosia, Cyprus, 1678
    • Recruiting
    • University of Cyprus
    • Contact: Fofi Constantinidou, Ph.D.; Phone Number: 35722894437; Email: fofic@ucy.ac.cy
    • Contact: Fofi Constantinidou, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Condition; Combination of cognitive training with sham tDCS	Behavioral: Categorization Program; Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS
Experimental: Experimental Condition; Combination of cognitive training with active tDCS	Combination product: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorization Program Test 1	Semantic knowledge and classification behavior	Administered pre & post training with the Categorization Program, at 6 weeks
Categorization Program Test 2	Decision-Making and Rule based learning	Administered pre & post training with the Categorization Program, at 6 weeks
Probe Tasks	Decision-Making and Rule based learning	Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks
WHO BREF Quality of Life	general quality of life	before and after training, at 6 weeks
Dysexecutive Questionnaire	Test of everyday executive functioning behaviors; self and informant reports	pre and post training, at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitron Cognitive Assessment Battery	Tests of memory, reaction time, and executive Functioning	Pre & Post Testing, after completion of training at 6 weeks
fNIRS	Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses	pre and post training testing, after completion of training at 6 weeks

Collaborators and Investigators

• Sponsor: University of Cyprus
• Investigators: Principal Investigator: Fofi Constantinidou, Ph.D., University of Cyprus

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 101079001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be entered in an open access depository as per funding agency's requirements. IPD that underlie results in a publication
• IPD Sharing Time Frame: After data has been published, December 2026.
• IPD Sharing Access Criteria: upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No