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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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).
- Conditions
- Cognitive Function, Executive Function
- 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 group | Role | What they receive |
|---|---|---|
| TR group | Experimental | The training group (TR) will undergo 3 weeks of electroencephalography-based neurofeedback (EEG-NFB). EEG-NFB training. Receives: Behavioral: electroencephalography-based neurofeedback (EEG-NFB) |
| CO group | No intervention | Control 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.
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
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
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
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
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
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
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
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.
- First posted23 Jan 2023
- Study start1 Feb 2019
- Primary completion1 Apr 2020
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaroslaw Marusiak, Wroclaw University of Health and Sport Sciences
- Investigators
- Malgorzata Slowinska-Lisowska, Study director, Wroclaw University of Health and Sport Sciences
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Electroencephalography-based Neurofeedback Training on Cognitive Function in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05694377
- Acronym / sponsor ID
- 01/2019
- Conditions
- Cognitive Function, Executive Function
- Keywords
- neurofeedback, attention index, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 23 Jan 2023 (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.
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.
Detailed description
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two arms repeated measures control design
| Arm | Type | Receives |
|---|---|---|
| TR group | Experimental | Behavioral: electroencephalography-based neurofeedback (EEG-NFB)The training group (TR) will undergo 3 weeks of electroencephalography-based neurofeedback (EEG-NFB). EEG-NFB training. |
| CO group | No intervention | –Control group (CO) will not undergo 3 weeks of EEG-NFB training. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- lack of any neurological disorders including motor or cognitive deficits
- right-handedness
Key exclusion criteria (2 listed)
- diagnosed neurological disorders including motor or cognitive deficits
- left-handedness
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 |
|---|---|---|
| electroencephalography-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. | Behavioural | TR group |
Primary outcome
TMT-A
Time frame: 1 week prior EEG-NFB training program
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].
TMT-A
Time frame: up to 1 week post EEG-NFB training program
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].
TMT-B
Time frame: 1 week prior EEG-NFB training program
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].
TMT-B
Time frame: up to 1 week post EEG-NFB training program
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].
ST-I
Time frame: 1 week prior EEG-NFB training program
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].
ST-I
Time frame: up to 1 week post EEG-NFB training program
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].
ST-II
Time frame: 1 week prior EEG-NFB training program
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].
ST-II
Time frame: up to 1 week post EEG-NFB training program
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].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes. Only anonymized data will be shared with other researchers based on their request to principal investigator.
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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.
Malgorzata Slowinska-Lisowska study director
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
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.