Plain English Summary
Background and study aims
Executive functions can be defined as the control processes that deal with managing oneself and one's resources in order to achieve a goal. Executive functions are vital for success in daily life and rely on the intact neural functioning of a specific type of brainwaves, the theta oscillations. As executive dysfunctions are linked to abnormal activity of the theta oscillations in various neuropsychological disorders, the question arises if neurofeedback can increase the theta activity and as a result can improve executive functions in people with executive dysfunctions. Neurofeedback is a brain-computer-interface in which the otherwise unobservable theta activity is made visible to participants by providing a feedback signal on a computer screen. Thereby participants can monitor their current theta activity and learn to influence it using mental strategies. The aim of this study is to assess the feasibility and effectiveness of theta neurofeedback as a treatment for these patients.
Who can participate?
Patients aged 18 or older with executive dysfunctions
What does the study involve?
Participants are matched on age, gender and education and are pseudo-randomly allocated to the experimental group or the active control group. Both the experimental group and the active control group receive 8 neurofeedback sessions, provided on a daily basis (total duration 2-3 consecutive weeks). Participants in the experimental group receive immediate feedback on their current theta brain activity. Participants in the active control group receive pseudo/sham feedback, which is a replay of the feedback from the matched participant in the experimental group. Theta oscillations and executive functions are assessed before the neurofeedback training (pre-measurement), immediately after the training (post-measurement), and after 6 months (follow-up measurement).
What are the possible benefits and risks of participating?
In general, adverse effects of neurofeedback are rare.
Where is the study run from?
University of Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
February 2018 to February 2019
Who is funding the study?
University of Groningen (Netherlands)
Who is the main contact?
Dr Stefanie Enriquez-Geppert
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NF_EDys-pilot
Study information
Scientific title
The effect of frontal-midline theta neurofeedback on executive functioning
Acronym
NF_EDys
Study hypothesis
The trialists predict that the experimental group will show larger increases in theta amplitude over the neurofeedback sessions and show stronger improvements in executive functioning after the training in comparison to the active control group.
Ethics approval
Ethical Committee Psychology (ECP) of the University of Groningen, 21/03/2018, ref: RP_17232-O
Study design
Single-centre pseudo-randomized controlled trial (participants are matched on age, gender and education)
Primary study design
Interventional
Secondary study design
Pseudo-randomized controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Subjective executive dysfunctions
Intervention
Both the experimental group and the active control group receive 8 neurofeedback sessions, provided on a daily basis (total duration 2-3 consecutive weeks). Participants are matched on age, gender and education and pseudo-randomly assigned to either the experimental group or the active control group. Participants in the experimental group receive immediate feedback on their current theta brain activity. Participants in the active control group receive pseudo/sham feedback, which is a replay of the feedback from the matched participant in the experimental group.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Power of the theta oscillations measured with EEG before the neurofeedback training (pre-measurement), immediately after the training (post-measurement), and after 6 months (follow-up measurement)
Secondary outcome measures
1. Executive functions:
1.1. Memory updating assessed using the N-back task
1.2. Response inhibition assessed using the Stop-signal task
1.3. Task switching assessed using the letter-number switching task
1.4. Conflict monitoring assessed using the Stroop task
For these tasks the reaction times and accuracy percentage will be calculated. The tasks will be administered before the neurofeedback training (pre-measurement), immediately after the neurofeedback training (post-measurement), and 6 months after the training (follow-up measurement)
Overall trial start date
01/02/2018
Overall trial end date
28/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Subjective executive dysfunctions based on the BRIEF-A questionnaire
2. Aged 18 years or older
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Presence of severe psychiatric or neurologic disorder(s)
Recruitment start date
22/03/2018
Recruitment end date
15/07/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
University of Groningen
Department of Psychology
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands
Sponsor information
Organisation
University of Groningen
Sponsor details
Faculty of Behavioural and Social Sciences
Clinical & Developmental Neuropsychology — Department Clinical & Developmental Neuropsych.
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Rijksuniversiteit Groningen
Alternative name(s)
University of Groningen
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analyzed during the current study will be stored in a non-publically available repository of the University of Groningen, following the local rules for data storage and sharing. Consent from participants are obtained and all data will be anonymized. More exact details are currently unknown and will be made available at a later date.
Intention to publish date
28/02/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list