The sample size is desperately small, which means that many of the pre- and post-test differences failed to meet the necessary 95% confidence (p=0.05) for a conclusion. This was exaggerated by the number of subjects who could not complete specific tests.
qEEG had issues with kids tolerating the electrodes or remaining at rest. Sensations (sound, touch, vision) and activity (blinking, talking, moving) all cause brain activity that interfere with the qEEG results, which require the patient to be relaxed and quiescent.
Posturography was problematic because it was hard to get the kids to keep their eyes closed and stand still for the eyes-closed tests. And some "subjects were even jumping up and down on the CAPS force platform". Hell, put any kid on a 10cm thick foam mat... they're going to jump. I would too! But this prevented many of the posturography tests from achieving p<0.05.
A larger initial cohort would have provided more solid results... but of course there's the time and cost issue involved in getting that.
In summary, I believe the study is very promising. Where results have achieved the necessary confidence they are very good. The qualitative assessments are also strong. But a frustratingly large proportion of the quantitative tests did not provide confidence.
We will have to wait until Monday (at least) to find out whether we have enough out of this study to get certification from the FDA to make the claims we would like to make.
Hopefully we will have a full investor presentation on Monday (or a suspension until we do) so we can get a clear feel for the way forward.
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