Brain Research and Integrative Neuroscience Network for COVID-19

NCT06517706 | Recruiting DMC

• 1 other identifier: 101079001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Training; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Cognitron Cognitive Assessment Battery

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

• fNIRS

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

Study Arms (2)

Control Condition

SHAM COMPARATOR

Combination of cognitive training with sham tDCS

Behavioral: Categorization Program

Experimental Condition

EXPERIMENTAL

Combination of cognitive training with active tDCS

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

Interventions

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

Experimental Condition

Categorization Program BEHAVIORAL

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

Control Condition

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cyprus: lead

Study Sites (1)

University of Cyprus

Nicosia, Cyprus, 1678, Cyprus

RECRUITING

Related Links

• Project website

Study Officials

• Fofi Constantinidou, Ph.D.

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fofi Constantinidou, Ph.D.

CONTACT

+357 22892078; fofic@ucy.ac.cy

Eleni Michael

CONTACT

+35722895190; can@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomly assigned to the experimental and control group. Both groups will receive cognitive rehabilitation. The experimental group control group will also active tDCS treatment whereas the control will receive inactive or sham tDCS treatment
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Random Assignment

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: November 15, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After data has been published, December 2026.
• Access Criteria: upon request

Locations

CY (1)