Condition category
Mental and Behavioural Disorders
Date applied
11/12/2018
Date assigned
17/01/2019
Last edited
17/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

www.neurofeedback-rug.nl

Contact information

Type

Scientific

Primary contact

Dr Stefanie Enriquez-Geppert

ORCID ID

Contact details

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

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

https://www.rug.nl/

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

Publication citations

Additional files

Editorial Notes