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Research in context

Evidence before this study


Attention-deficit hyperactivity disorder (ADHD) is a prevalent childhood disorder that is often
maintained throughout development and persists into adulthood, leading to substantial
problems in daily functioning. Although pharmacotherapy is considered the first-line treatment
for ADHD at all ages (at least for severe cases), non-pharmacological therapies might be
equally effective without the risk of drug side-effects. Some studies have shown that
electroencephalographic (EEG) neurofeedback improves parent-rated ADHD symptoms in
children and adolescents. However, adequate and well controlled studies to support its use are
scarce, particularly in adults. We searched PubMed with the search terms “ADHD”,
“neurofeedback”, “adults,” and “clinical trial” for articles published in English between Oct 1,
2010, and March 31, 2017. This search identified two feasibility studies that investigated the
effects of neurofeedback when compared with either no intervention or a sham control in small
groups of students prone to ADHD. Although the first study of neurofeedback versus no
intervention reported beneficial effects, the second study of neurofeedback versus sham control
found no advantage of neurofeedback. The PubMed search additionally identified one
randomized controlled trial. This trial showed that, compared with waiting-list control,
neurofeedback promoted improvement of self-reported ADHD symptoms but did not show
transfer of learning to a computerized assessment of executive functions.
Added value of this study
In this first randomized, adequately controlled, triple-blind investigation of neurofeedback for
the treatment of adults with ADHD, we found no superior efficacy of neurofeedback to sham
neurofeedback or meta-cognitive therapy in the treatment of ADHD symptoms. Furthermore,
targeted EEG bands (θ:β) remained unaffected by neurofeedback training, and clinical
improvements were unrelated to the EEG θ-to-β power ratios across assessments in all
treatment conditions.
Implications of all the available evidence
This study adds to first evidence from other studies that investigated the effects of
neurofeedback in children with ADHD or other clinical disorders and observed no advantage
for neurofeedback when compared with sham treatments. Our results suggest that although
neurofeedback training is effective in reducing ADHD symptoms it neither outperforms sham
neurofeedback nor group psychotherapy. As such, neurofeedback cannot be recommended as
an efficient approach in the treatment of adults with ADHD.
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sessions. In the sham neurofeedback group, 15 sessions of sham neurofeedback were followed
by 15 sessions of verum neurofeedback over 15 weeks. Participants in the meta-cognitive
therapy group received 12 weekly scheduled group sessions of CBT-oriented psychotherapy.
We decided not to provide a pure sham condition over 30 sessions on the basis of ethical
considerations assuming that participants would benefit only from real but not from sham
neurofeedback therapy. Thus, by administering proper neurofeedback to all participants, we
ensured that everyone eventually received actual treatment.13 Neurofeedback training was
done by experienced master-level clinical psychologists who were trained in neurofeedback
and masked to the treatment condition. The meta-cognitive therapy was led by two clinical
psychologists experienced in ADHD therapy for adults and trained in meta-cognitive therapy.
A commercially available neurofeedback system (NeXus-32; MindMedia, Herten,
Netherlands) and software (BioTrace+ version 2012) were used for neurofeedback and sham
neurofeedback protocols. Neurofeedback training was implemented for EEG activity at the
vertex, with use of a linked mastoid reference scheme and a sampling frequency of 256 Hz.
Impedance was kept below 5 kΩ. The EEG signal was high-pass filtered at 1 Hz and low-pass
filtered at 45 Hz. Every session consisted of a resting state (baseline) condition of 4 min with
participants’ eyes closed, three training epochs (7 min each), and a transfer phase without
feedback for an additional 7 min. The aim of the neurofeedback training was to decrease θ
activity (4–8 Hz, as indicated by a histogram on the left side of the screen) while increasing β
activity (13–21 Hz, represented as a histogram on the right side of the screen). Positive
feedback was provided by visual effects (moving bubbles in the middle of the screen) when θ
activity remained below threshold and β activity above threshold, otherwise bubbles stopped
moving (appendix). The reward thresholds were automatically adjusted every 15 s (on the basis
of real-time signal) to provide positive feedback about 80% of the time.15,16,22 The feedback
process was automatic for standardization purposes, to minimize variability in terms of the type
of feedback provided, and to enhance replicability of the procedure.
The sham neurofeedback protocol was identical to the verum neurofeedback protocol except
for the origin of the EEG signal displayed on the participants’ screens. In the sham condition,
participants were presented with a pre-recorded signal from an individual who participated in
the verum neurofeedback group of the study.
Therefore, at the beginning of the training, a computer program allocated each participant of
the sham neurofeedback condition to a participant of the verum neurofeedback condition and
this assignment remained stable throughout the treatment.
At the start of each neurofeedback session, the trainer entered the participant’s identification
details and the computer program subsequently assigned the participant to the respective
session signal of the matched verum participant (sham condition) or the verum condition (real
signal). This allocation procedure was done while the monitor was black; therefore, the trainer
was never aware of the participants’ randomization status throughout the therapy.