Clinical evidence​

Effectiveness of the brain stimulation headset

The Flow brain stimulation headset uses a technique called Transcranial Direct Current Stimulation (tDCS). It works by sending a weak electric current, the equivalent of a 9 volt battery, into the frontal parts of the brain. The result is increased activity in the left part of the frontal lobe and decreased activity in the right part of the brain.

There are several reasons why increasing activity in this area of the brain is beneficial for people suffering with depression. In such cases, individuals often have an imbalance of activity between the hemispheres in the front of the brain.1 When we stimulate the left side of the brain in people with depression, the symptoms have been shown to decrease.2,3 The electrical stimulation restores activity, promoting the correct balance between both frontal lobes.

Research into and practice of tDCS has also demonstrated long-term alteration in brain activity through increased neuroplasticity in the stimulated areas.4 Put simply, tDCS helps increase the brain’s ability to change in certain key areas over time – an important aspect of tackling long-term symptoms of depression.

The results of the studies indicate that tDCS has approximately the same effect as antidepressant medication – but with fewer and less-severe side effects.

A collection of the RCT studies conducted until 2016 can be found in a review from the same year, published in The British Journal of Psychiatry and showing a decrease in depression. The result of the study showed that: “The effect size of tDCS treatment was comparable with those reported for repetitive transcranial magnetic stimulation and antidepressant drug treatment in primary care.2

The results in one of the most recently published randomised controlled trial on 245 patients shows that 41% of the patients had a 50% reduction or more in their depression symptoms but that a higher dose of the antidepressant escitalopram was superior in efficacy by a statistically significant margin.3

The Flow headset is technically and clinically equivalent to the devices and protocols used in these large clinical studies.

 

1. Grimm, S., Beck, J., Schuepbach, D., Hell, D., Boesiger, P., Bermpohl, F., et al., (2008). Imbalance between left and right dorsolateral prefrontal cortex in major depression is linked to negative emotional judgment: an fMRI study in severe major depression. Biological Psychiatry 63:369–376.
https://www.ncbi.nlm.nih.gov/pubmed/17888408

2. Brunoni, A. R., Moffa, A. H., Fregni, F., Palm, U., Padberg, F., Blumberger, D. M., … Loo, C. K. (2016). Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. The British Journal of Psychiatry : The Journal of Mental Science 208(6), 522–531. https://doi.org/10.1192/bjp.bp.115.164715

3. Brunoni, A. R., Moffa, A. H., Sampaio-Junior, B., Borrione, L., Moreno, M. L., Fernandes, R. A., Benseñor, I. M. (2017). Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. New England Journal of Medicine 376 (26), 2523–2533. https://doi.org/10.1056/NEJMoa1612999

4. Nitsche, M.A., Paulus, W., (2001). Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology 57:1899–1901
https://doi.org/10.1212/WNL.57.10.1899

Safety

Several large meta analyses have shown the side effects of the brain stimulation technique used by Flow – Depression to be mild and transient.

The current of tDCS is equivalent to a small 9 volt battery and its pulse is, as a comparison, 400 times weaker than the commonly used electroconvulsive therapy (ECT) treatments.

A large Safety update on the current state of tDCS was performed 2016 by Bikson et al. The study comprised 27 of the most published researchers in the field and concluded that:

“To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 coulombs) has not produced any reports of a serious adverse effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.”5

Aparicio was the lead author for a meta analysis performed in 2016 where he and his fellow researchers looked at the tolerability of tDCS based on 64 studies with 2262 participants. The dropout rates were similar for active and “sham” tDCS (meaning that there were no current administered) indicating that serious adverse events are not more common for active tDCS compared to sham and that the tolerability of active tDCS is good.6

The large (n=245) recent RCT by Brunoni et al. (2017) has a thorough analysis of all adverse events reported during the trial and provides a statistical comparison between the active tDCS and placebo/sham tDCS groups. The adverse events that were significantly more frequent with the active tDCS were tingling, skin redness and tinnitus.3

In 2018, Nikolon et al., performed a meta analysis loooking at 158 studies (total 4130 participants) “The incidence of adverse events (examined per session, by proportion of participants, and by the number of studies reporting AEs) did not increase with higher levels of tDCS exposure.7

5. Bikson et al.,(2016). Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimulation, 9(2016), 641–661. http://dx.doi.org/10.1016/j.brs.2016.06.004

6. Aparício et al.,(2016). A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Brain Stimulation, 9(5), 671–681. https://doi.org/10.1016/j.brs.2016.05.004

7. Nikolin et al., (2018). Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Brain Stimulation 11 (2018) 278-288. https://doi.org/10.1016/j.brs.2017.10.020

Certification

In the process of becoming a medical device Flow went through a strict regulatory process with the British Standard Institute (BSI), a notified body, to ensure its effectiveness and safety according to the requirements of the European Commission. Flow is classified as a medical device class 2a.

Effectiveness of the brain stimulation headset

The Flow brain stimulation headset uses a technique called Transcranial Direct Current Stimulation (tDCS for short). It works by sending a weak electric current, the equivalent of a 9 volt battery, into the frontal parts of the brain. The result is increased activity in the left part of the frontal lobe and decreased activity in the right part of the brain.

PICTURE OF BRAIN ACTIVITY

There is several reasons why increasing activity in this area of the brain is beneficial for people suffering from depression. Individuals suffering from depression often have an imbalance in activity between the hemispheres in the front of the brain [1]. When we stimulate the left side of the brain in people with depression, the depression symptoms have been shown to decrease [3,4,5,6,7,11]. The electrical stimulation restores activity, promoting the correct balance between both frontal lobes.

Research and practice of tDCS have also demonstrated long-term alteration in brain activity through increased neuroplasticity in the stimulated areas [8]. Put simply, tDCS helps increase the brain’s ability to change in certain key areas over time—an important aspect in tackling depression symptoms long term.

The results of the studies indicate that tDCS has approximately the same effect as antidepressant medication – but with fewer and less-severe side effects.

The results in one of the latest randomised controlled trial on 245 patients (Ref 1) shows that 41% of the patients had a 50% reduction or more in their depression symptoms. A collection of the RCT studies conducted until 2016 can also be found in a review from the same year, published in The British Journal of Psychiatry. (Ref 2)

The Flow headset is technically and clinically equivalent to the devices and protocols used in these large clinical studies.

REFERENCES

1. Brunoni, A. R., Moffa, A. H., Sampaio-Junior, B., Borrione, L., Moreno, M. L., Fernandes, R. A., Benseñor, I. M. (2017). Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. New England Journal of Medicine 376 (26), 2523–2533. https://doi.org/10.1056/NEJMoa1612999
2. Brunoni, A. R., Moffa, A. H., Fregni, F., Palm, U., Padberg, F., Blumberger, D. M., … Loo, C. K. (2016). Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. The British Journal of Psychiatry : The Journal of Mental Science 208(6), 522–531. https://doi.org/10.1192/bjp.bp.115.164715
MORE REFERENCES TO COME

Safety
The current of tDCS is comparable to a small 9 volt battery and its pulse is, as a comparison, 400 times weaker than the commonly used electroconvulsive therapy (ECT) treatments. Several large metaanalyses have shown the side effects of the brain stimulation technique used by Flow – Depression to be mild and transient. Aparicio et al. (2016) performed a meta-analysis of tolerability of tDCS based on 64 studies with 2262 participants. The dropout rates were similar for active and sham tDCS indicating that serious adverse events are not more common for active tDCS compared to sham and that the tolerability of active tDCS is good.
The large (n=245) recent RCT by Brunoni et al. (2017) has a thorough analysis of all adverse events reported during the trial and provides a statistical comparison between the active tDCS and placebo/sham tDCS groups. The adverse events that were significantly more frequent with the active tDCS were tingling, skin redness and tinnitus.
The following table shows the adverse events reported in the

Is tDCS suitable for my patient (LINK to form)

References

WILL BE ADDED

 

Certification

In the process of becoming a medical device Flow went through a strict regulatory process with the British Standard Institute (BSI), a notified body, to ensure its effectiveness and safety according to the strict requirements of the European Commission. Flow is classified as a medical device class 2a. 

 Read more (LINK)