ClinicalTrials.gg
Status unknownNCT05694377Updated Jan 23, 2023

Effects of the EEG-neurofeedback on Cognitive Function

An interventional study of electroencephalography-based neurofeedback (EEG-NFB) in Cognitive Function and Executive Function, sponsored by Wroclaw University of Health and Sport Sciences. Status unknown at 1 site in Poland. Open to male participants aged 20 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Feb 2019, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 25 Years
Sex
Male
01

Study 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. 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

2. 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).

02

Conditions studied

  • Cognitive Function
  • Executive Function

Keywords

  • neurofeedback
  • attention index
  • cognitive function
03

In context

Lead sponsor

Wroclaw University of Health and Sport Sciences is the lead sponsor of 46 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • diagnosed neurological disorders including motor or cognitive deficits
  • left-handedness
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    TR group

    The training group (TR) will undergo 3 weeks of electroencephalography-based neurofeedback (EEG-NFB). EEG-NFB training.

    Behavioral: electroencephalography-based neurofeedback (EEG-NFB)

  • No intervention
    CO group

    Control group (CO) will not undergo 3 weeks of EEG-NFB training.

Interventions

  • Behavioralelectroencephalography-based neurofeedback (EEG-NFB)

    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.

06

What researchers measure

Primary outcomes

  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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: 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 \[s\].

    Time frame: up to 1 week post EEG-NFB training program

07

Study locations

1 site
  • University School of Physical Education in Wroclaw
    Wroclaw, Lower Silesian Voivodeship 51-612, Poland
08

References and documents

Individual participant data

Plan to share: Yes — Only anonymized data will be shared with other researchers based on their request to principal investigator.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: Data will be available from January the the 1'st of 2024.

Access criteria: Data will be shared with other researchers based on their request to principal investigator.

Data sharing details ↗ · awf.wroc.pl

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05694377
Lead sponsor
Wroclaw University of Health and Sport Sciences
Responsible party
Jaroslaw Marusiak (Principal Investigator - Director of Kinesiology Department at the University School of Physical Education in Wroclaw, Wroclaw University of Health and Sport Sciences) — Principal investigator
First posted
Jan 23, 2023
Start date
Feb 1, 2019
Primary completion
Apr 1, 2020
Completion
Apr 30, 2023 (estimated)
Last update
Jan 23, 2023

Study contacts

Malgorzata Slowinska-Lisowska
study director · Wroclaw University of Health and Sport Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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