Neurofeedback for improved mental functioning

ISRCTN	ISRCTN19822753
DOI	https://doi.org/10.1186/ISRCTN19822753
Secondary identifying numbers	NF_EDys-pilot

Submission date: 11/12/2018
Registration date: 17/01/2019
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Stefanie Enriquez-Geppert
Scientific

Faculty of Behavioural and Social Sciences
Clinical & Developmental Neuropsychology — Department Clinical & Developmental Neuropsych.
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Study information

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
Study setting(s)	Other
Study type	Other
Scientific title	The effect of frontal-midline theta neurofeedback on executive functioning
Study acronym	NF_EDys
Study objectives	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(s)	Ethical Committee Psychology (ECP) of the University of Groningen, 21/03/2018, ref: RP_17232-O
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2018
Completion date	28/02/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Subjective executive dysfunctions based on the BRIEF-A questionnaire 2. Aged 18 years or older
Key exclusion criteria	Presence of severe psychiatric or neurologic disorder(s)
Date of first enrolment	22/03/2018
Date of final enrolment	15/07/2018

Locations

Countries of recruitment

Netherlands

Study participating centre

University of Groningen

Department of Psychology
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Sponsor information

University of Groningen
University/education

Faculty of Behavioural and Social Sciences
Clinical & Developmental Neuropsychology — Department Clinical & Developmental Neuropsych.
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Website	https://www.rug.nl/
"ROR"	https://ror.org/012p63287

Funders

Funder type

University/education

Rijksuniversiteit Groningen
Private sector organisation / Universities (academic only)

Alternative name(s): University of Groningen, RUG
Location: Netherlands

Results and Publications

Intention to publish date	28/02/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	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.