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Cognitive FunctionNCT05694377

Effects of the EEG-neurofeedback on Cognitive Function

A study testing electroencephalography-based neurofeedback (EEG-NFB) in people with Cognitive Function and Executive Function, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Executive function play a key role in boosting human behavioural performance. Based on scientific literature, it is still controversial whether electroencephalography-based neurofeedback (EEG-NFB) represents an effective technique for enhancing healthy adults' executive function. Read more about this study

Who is it for?
Ages 20 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cognitive Function, Executive Function
What is being tested?
electroencephalography-based neurofeedback (EEG-NFB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePoland
Study dates
1 Feb 2019to 30 Apr 2023
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 20 to 25 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • lack of any neurological disorders including motor or cognitive deficits
  • right-handedness

Who cannot join

  • diagnosed neurological disorders including motor or cognitive deficits
  • left-handedness

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • University School of Physical Education in Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 51-612

Other trials in Poland

About this study

Official title: Effects of the Electroencephalography-based Neurofeedback Training on Cognitive Function in Healthy Young Men

Executive function play a key role in boosting human behavioural performance. Based on scientific literature, it is still controversial whether electroencephalography-based neurofeedback (EEG-NFB) represents an effective technique for enhancing healthy adults' executive function. This study evaluates generalized effects of 3-week EEG-NFB training, using self-regulation of the theta to beta wave ratio (TBR), on executive function in healthy adults. The subjects are an uniform group of healthy young right-handed males divided into two equal groups. The trained group (TR) performs 3-week EEG-NFB training (three sessions per week) focused on a cognitive self-regulation of TBR (to achieve the lower TBR values as beneficial cognitive effect), while the control group (CO) does not participate in the EEG-NFB training. Cognitive function are rated before and after 3-week EEG-NFB training by psychological tests: Trail Making Test (TMT, parts A and B) and the Stroop Test (ST, parts I and II). This project is important for the future development of effective EEG-NFB protocols to be used by healthy people to improve their behavioural performance.

Read the detailed description
  1. MATERIALS AND METHODS

2.1. Subjects A total of 50 healthy male students will be randomly assigned to one of two groups of 25 subjects each using a computerized randomization method. The trained group will undergo 3 weeks of EEG-NFB training, whereas the control group will not undergo training. Inclusion criteria for study participation will be lack of any neurological disorders and motor or cognitive deficits, lack of neurological incident in the past, age between 20 to 25 years, male sex, and right-handedness (this inclusion criteria will be to avoid an influence of lateralization and gender on psychological tests outcomes). The study was approved by the ethic committee of the University School of Physical Education in Wroclaw and will be carried out in accordance with the principles outlined in the Declaration of Helsinki.

2.2. Experimental procedure TR and CO groups will be each tested twice in the same time periods, i.e., before 3 weeks period of EEG-NFB training (PRE) and after the training period (POST). During the PRE and POST experimental sessions, all subjects will undergo psychological testing to evaluate executive function. PRE testing in the both groups will be performed 1 to 4 days before the first day of EEG-NFB training period, whereas POST testing will be performed 1 to 4 days after the last day of EEG-NFB training period to ensure that the measurements will be not due to the effects of the last single training session in the TR group.

2.3. Psychological assessment All subjects will undergo cognitive testing (TMT and ST), which will be performed by an experienced researcher. There will be two parts to the TMT: TMT-A, in which a subject connects numbers in sequential order; and TMT-B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.). The former is used to examine cognitive processing speed, while the latter assesses executive function. The ST also consists of two parts: ST-I, in which a subject reads a list of 40 words, which are names of colours printed in the colour itself; and ST-II, where colour names are printed in an incongruent colour and the subject is required to ignore the word and correctly name the ink colour. The former is used as a measure of processing speed and the latter to test selective attention and inhibition. The subjects will be provided with instructions prior to starting the TMT and ST. In both ST tests parts subjects will have the same instruction as "name the colour of ink", and will not be informed in ST-I that all name/ink are matched. All tests (both parts of TMT and ST) will be preceded by preparatory/training trials, a similar but shorter version of main tests. Before starting each test, subjects will be instructed to concentrate and to make use their maximal attention skills during testing session. In both tests (TMT and ST), the time taken to complete the test will be used as the performance measure, with a shorter time reflecting a better performance. The tests will be administered in a quiet room with only one and always the same investigator present.

2.4. EEG-NFB training procedure The EEG-NFB training program will involve nine training sessions (three times a week over a 3-week period) each lasting 30 min. EEG-NFB training will be conducted with ProComp Infiniti Encoder and BioGraph Infiniti Software v.5.1.3. The training protocol will be set to decrease the EEG TBR value. For the 12 training sessions, all participants will be subjected the same EEG-NFB protocol at C3 (according to the 10-20 system), which is related to Brodmann area 4. This location is selected because the TMT and ST used to quantify the EEG-NFB effect are also related to activity in this brain region. The EEG-NFB training sessions consists of a 20-s baseline period (i.e., with no feedback), 30-min feedback presentation, and another 20-s baseline period. Subjects will be seated in front of a computer screen and animations will be used as feedback; the animation starts when the subject is sufficiently focused for 20 s. Three 10-min animations (flying duck, roller coaster ride, and moving ball) will be shown to the subject during each EEG-NFB training session. The raw EEG signal, TBR value over time, EEG signal noise, and EEG theta and beta wave amplitudes will be recorded.

TBR values will be recorded and calculated for each training session for the TR group and will be compared between the beginning of the first and beginning of the last EEG-NFB training sessions, to determine whether the 3-week training lead to decrease of the TBR value.

2.5. Statistical analysis The Shapiro-Wilk test will be used to estimate the distribution of psychological parameters. The Wilcoxon signed-rank test or Student's t-test will be used to assess the statistical significance of differences for paired sample comparisons (i.e., between PRE and POST testing sessions). The Mann-Whitney test or Student's t-test will be used for unpaired sample comparisons (i.e., between TR and CO groups). Magnitude/importance of differences will be calculated using the Cohen effect size d value for results of the psychological tests; a value of 0 indicates no effect, whereas values > 0.2, >0.6, and > 0.8 indicates small, moderate, and large effects, respectively. P value ≤ 0.05 will be taken as statistically significant for all analyses. All statistical analyses will be performed using SPSS Statistics 22.0 software (IBM, Armonk, NY, USA).

Being tested
electroencephalography-based neurofeedback (EEG-NFB)
Keywords
neurofeedback, attention index, cognitive function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroencephalography-based neurofeedback (EEG-NFB)Behavioural

    The EEG-NFB training program will involve nine training sessions (three times a week over a 3-week period) each lasting 30 min. EEG-NFB training will be conducted with ProComp Infiniti Encoder and BioGraph Infiniti Software v.5.1.3. The training protocol will be set to decrease the EEG TBR value. For the 12 training sessions, all participants will be subjected the same EEG-NFB protocol at C3 electrode. The EEG-NFB training sessions consists of a 20-s baseline period (i.e., with no feedback), 30-min feedback presentation, and another 20-s baseline period. Subjects will be seated in front of a computer screen and animations will be used as feedback; the animation starts when the subject is sufficiently focused for 20 s. Three 10-min animations (flying duck, roller coaster ride, and moving ball) will be shown to the subject during each EEG-NFB training session. The raw EEG signal, TBR value over time, EEG signal noise, and EEG theta and beta wave amplitudes will be recorded.

Study groups in NCT05694377
Study groupRoleWhat they receive
TR groupExperimentalThe training group (TR) will undergo 3 weeks of electroencephalography-based neurofeedback (EEG-NFB). EEG-NFB training.
Receives: Behavioral: electroencephalography-based neurofeedback (EEG-NFB)
CO groupNo interventionControl group (CO) will not undergo 3 weeks of EEG-NFB training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TMT-A

    trail making test, part A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: 1 week prior EEG-NFB training program

  2. TMT-A

    trail making test, part A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: up to 1 week post EEG-NFB training program

  3. TMT-B

    trail making test, part B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: 1 week prior EEG-NFB training program

  4. TMT-B

    trail making test, part B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: up to 1 week post EEG-NFB training program

  5. ST-I

    Stroop Test, part I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: 1 week prior EEG-NFB training program

  6. ST-I

    Stroop Test, part I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: up to 1 week post EEG-NFB training program

  7. ST-II

    Stroop Test, part II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: 1 week prior EEG-NFB training program

  8. ST-II

    Stroop Test, part II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

    Measured: up to 1 week post EEG-NFB training program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start1 Feb 2019
  3. Primary completion1 Apr 2020
  4. Study completion30 Apr 2023 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
two arms repeated measures control design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694377
Sponsor's protocol ID
01/2019
Status last verified
Jan 2023
First submitted
6 Jan 2023
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only anonymized data will be shared with other researchers based on their request to principal investigator.

Questions about this trial

What is this clinical trial studying?

A study testing electroencephalography-based neurofeedback (EEG-NFB) in people with Cognitive Function and Executive Function, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

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 2 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. 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 Poland. 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. 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?

Results are not available in the source record.

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?

TMT-A (time frame: 1 week prior EEG-NFB training program). The study lists 8 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 23 Jan 2023.

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