Cognitive TrainingBRAINNNCT06517706
Brain Research and Integrative Neuroscience Network for COVID-19
A study testing Combination of tDCS (device) with cognitive training (behavioral) and Categorization Program in people with Cognitive Training and Transcranial Direct Current Stimulation, run by University of Cyprus at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Cognitive Training, Transcranial Direct Current Stimulation
- What is being tested?
- Combination of tDCS (device) with cognitive training (behavioral) and Categorization Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Nov 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reported cognitive difficulties due to COVID-19 infection
- WHO Long COVID criteria will be used
Who cannot join
- Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Combination of tDCS (device) with cognitive training (behavioral), Categorization Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of tDCS (device) with cognitive training (behavioral)Combination product
Participation in 15 one-hour sessions distributed over five weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program
Categorization ProgramBehavioural
Participation in 15 one-hour sessions distributed over five weeks. During each session participants will receive cognitive training with the Categorization Program and sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Sham comparator | Combination of cognitive training with sham tDCS Receives: Behavioral: Categorization Program |
| Experimental Condition | Experimental | Combination of cognitive training with active tDCS Receives: Combination Product: Combination of tDCS (device) with cognitive training (behavioral); Behavioral: Categorization Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorization Program Test 1
Semantic knowledge and classification behavior
Measured: Administered pre & post training with the Categorization Program, at 6 weeks
Categorization Program Test 2
Decision-Making and Rule based learning
Measured: Administered pre & post training with the Categorization Program, at 6 weeks
Probe Tasks
Decision-Making and Rule based learning
Measured: 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
Measured: before and after training, at 6 weeks
Dysexecutive Questionnaire
Test of everyday executive functioning behaviors; self and informant reports
Measured: pre and post training, at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start15 Nov 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Random Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fofi Constantinidou, University of Cyprus
- Investigators
- Fofi Constantinidou, Ph.D., Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517706
- Sponsor's protocol ID
- 101079001
- Acronym
- BRAINN
- Status last verified
- Dec 2024
- First submitted
- 19 Jul 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be entered in an open access depository as per funding agency's requirements. IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)
- ClinicalTrials.gov ID
- NCT06517706
- Acronym / sponsor ID
- BRAINN / 101079001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Random Assignment
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Sham comparator | Behavioral: Categorization ProgramCombination of cognitive training with sham tDCS |
| Experimental Condition | Experimental | Combination Product: Combination of tDCS (device) with cognitive training (behavioral), Behavioral: Categorization ProgramCombination of cognitive training with active tDCS |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Reported cognitive difficulties due to COVID-19 infection
- WHO Long COVID criteria will be used
Key exclusion criteria (1 listed)
- Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of tDCS (device) with cognitive training (behavioral)Participation in 15 one-hour sessions distributed over five weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program | Combination product | Experimental Condition |
| Categorization ProgramParticipation in 15 one-hour sessions distributed over five weeks. During each session participants will receive cognitive training with the Categorization Program and sham tDCS | Behavioural | Control Condition, Experimental Condition |
Primary outcome
Categorization Program Test 1
Time frame: Administered pre & post training with the Categorization Program, at 6 weeks
Semantic knowledge and classification behavior
Categorization Program Test 2
Time frame: Administered pre & post training with the Categorization Program, at 6 weeks
Decision-Making and Rule based learning
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
WHO BREF Quality of Life
Time frame: before and after training, at 6 weeks
general quality of life
Dysexecutive Questionnaire
Time frame: pre and post training, at 6 weeks
Test of everyday executive functioning behaviors; self and informant reports
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized data will be entered in an open access depository as per funding agency's requirements. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fofi Constantinidou, Ph.D. principal investigator
University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of tDCS (device) with cognitive training (behavioral) and Categorization Program in people with Cognitive Training and Transcranial Direct Current Stimulation, run by University of Cyprus at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Categorization Program Test 1 (time frame: Administered pre & post training with the Categorization Program, at 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.