Effects of the EEG-neurofeedback on Cognitive Function

NCT05694377 | Unknown

• 1 other identifier: 01/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Function; Executive Function

Keywords

neurofeedback; attention index; cognitive function

Outcome Measures

Primary Outcomes (8)

• 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 \[s\].

  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 \[s\].

  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 \[s\].

  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 \[s\].

  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 \[s\].

  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 \[s\].

  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 \[s\].

  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 \[s\].

  up to 1 week post EEG-NFB training program

Study Arms (2)

TR group

EXPERIMENTAL

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

Behavioral: electroencephalography-based neurofeedback (EEG-NFB)

CO group

NO INTERVENTION

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

Interventions

electroencephalography-based neurofeedback (EEG-NFB) BEHAVIORAL

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.

TR group

Eligibility Criteria

• Age: 20 Years - 25 Years
• Gender Eligibility Details: participant eligibility is based on self-representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (1)

University School of Physical Education in Wroclaw

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Study Officials

• Malgorzata Slowinska-Lisowska

  Wroclaw University of Health and Sport Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person analysing the outcomes will be blinded to the subjects allocation to the groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Director of Kinesiology Department at the University School of Physical Education in Wroclaw

Model Details: two arms repeated measures control design

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 23, 2023
• Study Start: February 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 30, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

PL (1)