The science of Flow

Flow Neuroscience is a medical device company. Our mission is to conduct research around mental health among world-class institutions, and build credible, scientific evidence within the healthcare environment. Today, Flow Neuroscience works with some of the world’s leading researchers in the field of brain stimulation to build at-home medical devices so that more patients than ever before can be treated in a safe and effective way from the comfort of their home.

The Flow device

During the last 20 years, evidence has emerged about the efficacy of Transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, which works by stimulating the brain using a weak, barely noticeable, electric signal in order to change neural activity patterns beneath the stimulated areas.

Numerous scientific studies have shown that this technique has similar levels of efficacy on clinically depressed patients as talk therapy (e.g. Cognitive Behavioural Therapy) or antidepressant medications. What sets tDCS apart from medication is that it has almost no side-effects, besides slight irritation of the skin under the stimulation area and mild headaches that pass 30 minutes after the stimulation. tDCS is currently used on a small scale by researchers, specialised labs, and hospitals in countries, including the US, Germany and Italy. The results of a recent randomised controlled trial (RCT) on 245 patients show that 41% of the patients had a 50% reduction or more in their depression symptoms1.

A collection of eight RCT studies conducted up until 2016 can be found below2. A 2019 meta-analysis also found tDCS to be efficacious3.

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 (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

3. Mutz et al (2019). Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis: BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1079 

 

The “Flow – Depression” app

While users wear the device, they interact with an AI-powered app therapy program. The app provides original video content, information and advice about lifestyle changes specifically aimed at reducing depression. It teaches the user about depression, and how to reduce it, using techniques for improved sleep,3 healthier eating4 effective exercise5 and stress-reducing meditation.6 Below you can find a few examples of the studies or scientific reports we have reviewed as part of the development of the Flow app.

The app is required to use the Flow device and is currently only available for iOS. Android support is coming soon.

Download Flow – Depression

3. The effectiveness of behavioural and cognitive behavioural therapies for insomnia on depressive and fatigue symptoms: A systematic review and network meta-analysis. Andrea Ballesio a, Maria Raisa Jessica V. Aquino b, Bernd Feige c, Anna F. Johann c, Simon D. Kyle d, Kai Spiegelhalder c, Caterina Lombardo a, Gerta Rücker e, Dieter Riemann c, Chiara Baglioni. Sleep Medicine Reviews 37 (2018) 114-129

4. Sugar intake from sweet food and beverages, common mental disorder and depression: prospective findings from the Whitehall II study. Anika Knüppel , Martin J. Shipley, Clare H. Llewellyn & Eric J. Brunner. SCIENTIFIC REPORTS | 7: 6287 | DOI:10.1038/s41598-017-05649-7

5. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. Felipe B. Schuch a, b, *, Davy Vancampfort c, d, Justin Richards e, Simon Rosenbaum f, Philip B. Ward f, Brendon Stubbs g, h. Journal of Psychiatric Research 77 (2016) 42e51

6. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis.Paul Blancka,∗, Sarah Perletha, Thomas Heidenreichb, Paula Krögera, Beate Ditzenc, Hinrich Bentsa, Johannes Mander. Behaviour Research and Therapy 102 (2018) 25–35

Safety

The Flow device is designed and produced in Sweden with maximum safety in mind. All materials, components and manufacturing processes are medical grade and compliant with the very strict European laws for medical devices.

Several large studies (so called meta analyses) have shown the side effects of the brain stimulation technique used by Flow to be mild and short-term. 7,8,9

Known side effects with Flow are:

  • Some skin redness under the electrode or near the
    electrode sites is normal, due to increased local blood
    flow, and will normally subside within approximately 30-60
    minutes after the end of use.
  • Skin irritation might be experienced beneath the
    stimulation electrodes. In this case, electrodes should
    NOT be reapplied to the irritated skin.
  • DO NOT apply the device over open wounds, or broken or damaged skin. This might create further irritation and/or skin damage.
Other effects that have been reported but that are very rare are:
  • An increase in the intensity of tinnitus

Stimulation should never been painful. Every user is different regarding skin sensitivity and you should always abort stimulation should you experience any pain.

Please contact a healthcare professional should your symptoms of depression or anxiety get worse.

7. Bikson et al., 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

8. Aparício et al., 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

9. Nikolin et al., 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

Precautions

You should NOT use the Flow headset without first consulting a doctor or healthcare professional. Using the Flow device poses minimal risk of injury. Even so, it is recommended to consider multiple treatment options. If symptoms worsen, make sure to contact a healthcare professional.

  • Do NOT use the Flow headset without first being diagnosed with depression or if you are under 18 years old.

Furthermore, take extra precaution and consult your physician if you:

  • experience suicidal thoughts or fantasizing about ending your life.
  • have a history of hypomanic/manic switches or episodes
  • have been diagnosed with bipolar disorder.
  • are suspected of having or have been diagnosed with epilepsy or have had seizures.
  • have open wounds, or broken or damaged skin at the stimulation site.
  • are pregnant or may be pregnant.
  • have a pre-existing neurological or neuropsychiatric condition.
  • have an active implanted medical device such as a cardiac pacemaker or neurostimulation device such as a spinal cord stimulator, vagal nerve stimulator, auricular stimulator, or deep-brain stimulating electrodes, or implanted defibrillator, or other implanted metallic or electronic device.
  • have a defect in neurocranium, an implant inside the skull, a cochlear implant, or an implanted hearing aid.
  • are suspected of having or have been diagnosed with a heart disease.
  • have recently had a surgical procedure

The Flow headset

In the last 20 years, strong evidence has emerged on the efficacy of tDCS, a less invasive, brain stimulation technique, based on stimulation of the brain using a weak, barely noticeable, electric signal in order to change neural activity patterns beneath the stimulated areas.

Numerous scientific studies have shown that this technique has similar levels of efficacy on clinically depressed patients as talk therapy (e.g. CBT) or antidepressant medications., What sets tDCS apart is that, few side-effects were observed aside of mild irritation of the skin under the anode (the plus electrode) and mild headaches that pass 30mins after the stimulation. tDCS is currently used at a small scale by researchers, specialized labs, and hospitals in the US and a few countries, like Germany and Italy.The results in the latest randomised controlled trial (RCT) study on 245 patients shows that 41% of the patients had a 50% reduction or more in their depression symptoms.  (LINK)
A collection of the 8 RCT studies conducted until 2016 can be found in this review from the same year.(LINK)
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 (26), 2523–2533. https://doi.org/10.1056/NEJMoa16129992. 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

The "Flow - Depression" app

While users wear the headset they interact with an AI-powered app therapy program. The app provides original video content, information and advice about lifestyle changes specifically aimed at reducing depression. It teaches the user about depression, and how to reduce it, using techniques for improved sleep (Ref 3), healthier eating(Ref 4)effective exercise(Ref 5) and stress-reducing meditation (Ref 6). Below you can find a few examples of the studies or scientific reports we have reviewed and that is the groundwork of the Flow app.

References

3.The effectiveness of behavioural and cognitive behavioural therapies for insomnia on depressive and fatigue symptoms: A systematic review and network meta-analysis.
Andrea Ballesio a, Maria Raisa Jessica V. Aquino b, Bernd Feige c, Anna F. Johann c, Simon D. Kyle d, Kai Spiegelhalder c, Caterina Lombardo a, Gerta Rücker e,
Dieter Riemann c, Chiara Baglioni. Sleep Medicine Reviews 37 (2018) 114-129

4.Sugar intake from sweet food and beverages, common mental disorder and depression: prospective findings from the
Whitehall II study. Anika Knüppel , Martin J. Shipley, Clare H. Llewellyn & Eric J. Brunner. SCIENTIFIC REPORTS | 7: 6287 | DOI:10.1038/s41598-017-05649-7

5. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. Felipe B. Schuch a, b, *, Davy Vancampfort c, d, Justin Richards e, Simon Rosenbaum f, Philip B. Ward f, Brendon Stubbs g, h. Journal of Psychiatric Research 77 (2016) 42e51

6. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis.Paul Blancka,∗, Sarah Perletha, Thomas Heidenreichb, Paula Krögera, Beate Ditzenc, Hinrich Bentsa, Johannes Mander. Behaviour Research and Therapy 102 (2018) 25–35