First double blind study shows neurofeedback no more effective than placebo- why this isn’t as bad as it sounds

Neurofeedback (NF) is no more effective than placebo in the treatment of ADHD symptoms show the results of the first double blind study to be conducted, one which made use of sham neurofeedback.

Previous studies have had control groups do cognitive exercises, to simulate a level of mental activity similar to that of NF training. However a better control group is one where every factor except the neurofeedback is kept constant. Here the subject undergoes NF training, however a computer simulated EEG is used instead of the user’s own, also known as SHAM neurofeedback. Thus it is possible to differentiate between the benefits of Neurofeedback itself, and other factors involved in the neurofeedback process (e.g. time spent with therapist, time spent focusing on task, clinical setting etc).

In this study even the NF practitioners were unaware of which group (test/placebo) the subjects had been assigned to. Typically reward thresholds are adjusted manually by practitioners, to make the training progressively harder as the subject improves. However as the practitioners were unaware of whether real or sham training was taking place, the thresholds were adjusted by computer software instead.

The study methodology was not typical in comparison to previous neurofeedback studies. According to a quantitative meta analysis of neurofeedback studies, the bulk of them  have involved either beta/theta training or SCP training protocols at specific sites. Instead in this study individualised training protocols were used.This training was designed to normalize deviations from normal QEEG. Sites to train were chosen by analysing QEEG, with the areas trained corresponding to the largest deviations.

Over a period of four months, both the control and test groups took part in 30 treatment sessions. At the end of the treatment period both groups made substantial improvements in reducing ADHD symptoms, and there was no difference in improvement between the NF and sham NF groups. When the subjects/parents were asked whether or not they thought they were given a placebo(SHAM NF) treatment, 75% of the NF group and 50% of the SHAM NF group thought they were given a placebo.

The fact that less than half the subjects/parents in the test group were aware that they were undergoing NF training shows that the computer set reward thresholds may have been set too high/ were improperly managed by the computer software. Or that there may have been a problem with the site selected for training. Typically a NF practitioner would have some control over training, (ability to change sites/ set reward threshold levels) however this wasn’t the case in this study, and the results show this. Because of this in a future larger study to be carried out by the authors, the reward thresholds will be set manually by a NF therapist.

Both those underdoing NF and sham neurofeedback were similarly uncertain as to if they were being given a placebo or not. While this shows that sham neurofeedback is a suitable placebo, i.e It’s not immediately obvious to the patient that they are not being given a placebo,  it also shows that there were problems with the NF training methodology as the subject should have been aware that they were undergoing NF (e.g. felt a sense of control) . The authors noted that they may have had better results if they had stuck to more popular NF methods such as (beta/theta & SCP training).

The result of this study seems to show that SHAM neurofeedback is beneficial. I won’t go as far as concluding that it shows that it’s as beneficial as neurofeedback, as based on what I think was improper Neurofeedback methodology I would say both the test and the placebo groups were given SHAM neurofeedback. So where is the benefit of SHAM neurofeedback coming from? Is it the clinical setting? the time with the practitioner? the effect of paying attention for a certain amount of time? In this case I’m going to go with the latter. I would say that SHAM neurofeedback is beneficial in the same way that meditation is beneficial. By focusing on one thing (e.g. breathing in meditation, maximising reward in NF training) for a certain amount of time, concentration improves, and this could be responsible for the reduction in ADHD symptoms. However I think neurofeedback may be easier than meditation for an ADHD person, as meditation relies on internal regulation, while neurofeedback relies on external feedback.

Summary

ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study
http://search.proquest.com.ezproxy.slv.vic.gov.au/docview/855953055/13D17177F2155D86E50/2?accountid=13905
Study year:2011
Study Demographics:14 children (ages 8-15)
Five of 8 children in the EEG-neurofeedback group and 4 of 6 children in the
placebo feedback group were medicated with psychostimulants
Study Methodology:randomized double blind study, feedback controlled placebo
ADHD defined via DSM-IV-TR criteria.
control group n=6, active group n=8.
Type of neurofeedback training:Individualised protocols. Designed to normalize deviations from normal QEEG. Sites to train were chosen by analysing QEEG, areas trained corresponding to largest deviations.
“The aim of the EEG-neurofeedback training was to normalize power within specific frequency bands and at specific electrode sites”

Frequency of training: 30 sessions over 4 months, 2 sessions a week.
How outcome was measured: EEG signal measured after training, data supplementary.
Efficacy in the present pilot study was measured by the total severity of inattention and hyperactive/impulsive symptoms of ADHD according to the ADHD DSM-IV scale (DuPaul et al. 1998), rated by the investigator in an interview with the parents. Severity of the ADHD symptoms were rated (with a score from 0 to 3) before training, after 6, 10, 20, 30 training sessions, and 6 months after the end of the training period.
Results: 75% of children and their parent(s) in the active neurofeedback group and 50% of children and their parent(s) in the placebo feedback group thought they received placebo feedback training.Analyses revealed significant improvements of ADHD
symptoms over time, but changes were similar for both groups.

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