Valkee Brain Stimulation Headset

Valkee substitutes the mood-elevating effects of the sun, by channeling safe bright light directly to photosensitive regions of the brain through the ear canal. That’s why Valkee increases energy, and can act as a preventative or treatment of mood swings. Valkee has CE Class II(a) medical device certification and is clinically tested.

Valkee scientific program and results

Valkee and its scientific program started in 2007 from the question: “What if our brain is sensitive to light?” Today, bright light is a well-accepted and effective treatment for a variety of mood swings and especially seasonal depression [1,2,3]. However, the mechanism of how light elevates the mood is not understood [4,5] and also extra-visual light generates significant responses [6]. Valkee’s scientific program focuses on resolving light-dependent biological processes and their therapeutic applications in mood swings, depression and sleep disorders for light channeled via ear canal.

Valkee’s scientific program has discovered the following:

  • Human brain is sensitive to light, not just our eyes
  • Valkee is effective for seasonal affective disorder (“winter blues”)
  • Valkee affects body’s circadian rhythm, and therefore can be an effective tool for sleep problems and circadian rhythm disturbances such as jetlag

This overview presents the key scientific publications by Valkee and University of Oulu, Finland.

92% of winter blues sufferers experienced total symptom relief with 8-12 minutes of Valkee daily

Picture: 9 of 10 seasonal affective disorder patients experienced total symptom relief in 4 weeks

In the clinical trial conducted in January and February 2009, 92.3% of study participants suffering from severe seasonal affective disorder – also known as winter blues – experienced total symptomatic relief with a daily 8-12 minute dose of Valkee. Winter depression symptoms such as tiredness, anxiety, cognitive performance, reduced sleep quality and food cravings were measured with the HAMD-17 psychiatrist rating scale, and the BDI-21 patient self-rating scale.

» Download the scientific poster presentation: Timonen et al. Transcranial Brain-Targeted Bright Light Treatment via Ear Canals in Seasonal Affective Disorder (SAD). 11th IFMAD Conference 2011.

“I am feeling better, and especially manage my job pressures.”

-Male 35 years

Human brain is sensitive to light, not just our eyes

Picture: Illustration of brain’s photosensitive areas and cells

The University of Oulu scientists discovered that our brain, not just eyes, are sensitive to light. The research localized the OPN3 protein – known as the light-sensitive photoreceptor protein – in all of the 18 evaluated areas of the brain [8]. These brain areas include the core areas of serotonin, melatonin and dopamine production and storage, and play key roles in mood, sleep and depression. The OPN3 protein is part of the opsin protein family: the same that is sensitive to light in our eyes.

A new study by Oulu University also found large amounts of a light-sensitive OPN4-protein, melanopsin, in the human brain. The mood-enhancing influence and circadian pacemaking properties of bright light when administered through eyes has been shown in earlier studies to be based on the OPN4-protein. In those studies the protein was found only on the retina. This new discovery now confirms that bright light, when channeled through the ear canal into the brain, can have an influence on brain functions.

» Download the scientific poster presentation: Nissilä et al. The Abundance and Distribution of the Encephalopsin (OPN3) in the Human Brain. Poster presentation at the Scandinavian Physiology Society Annual Meeting 2011, August 12-14

» Download the scientific poster presentation: Nissilä et al. The Abundance and Distribution of the Melanopsin (OPN4) Protein in the Human Brain.

“II used to eat a lot of chocolate during winter time and when stressed, but not anymore. My food cravings have ended.”

-Female 43 years

Valkee activates the human brain networks in placebo-controlled study

Picture: Bright light channeled via ear canal activates the visual brain areas in the placebo-controlled study (difference between the blue and red data series)

Bright light via the ear canal activates human brain networks as seen in brain imaging, controlled by a placebo group, suggesting that the brain tissue is inherently light-sensitive. In the study by the University of Oulu scientists, brain’s visual cortex and sensimotor components showed significantly increased activity against the placebo group.

» Download the scientific poster presentation: Starck T et al. Stimulating brain tissue with light – resting state fMRI analysis. Human Brain Mapping Conference 2009 & ISMRM Annual Conference 2011
» Link to peer-reviewed methodology paper online: Elseoud A et al. Group-ICA Model Order Highlights Patterns of Functional Brain Connectivity. Front Syst Neurosci. 2011; 5: 37

“Now I have energy to play with kids after getting back to home”

-Female 36 years

Valkee reports efficacy in randomized, controlled trial

Picture: Valkee significantly reduces BDI-21 depression scores across all study groups

89 subjects suffering from severe Seasonal Affective Disorder had a 12-min daily Valkee dose at home in three different randomly divided groups (1, 4, 9 lumen). The response rates in the sub-groups were 74-79% for seasonal depression and 47-62% for anxiety symptoms (at least 50% reduction in BDI-21 and HAMA score, respectively, at week 4) [7]. In comparison, traditional bright light typically produces 60% to 80% response rates in controlled trials in Seasonal Affective Disorder. Response rates in General Anxiety Disorder trials range from 39% to 59% using pregabalin [11,12,13,14], from 40% to 65% with duloxetine [15,16,17,18], and from 54% to 61% with venlaflaxine [17,18]. While the cross-trial comparison has its obvious scientific challenges, these comparative results in Seasonal Affective Disorder and anxiety symptoms can be considered promising for bright light via ear canal.

» Download the scientific poster presentation: Jurvelin H et al. Transcranial Brain-Targeted Bright Light Treatment via Ear Canals in Seasonal Affective Disorder (SAD) – a Randomized Controlled Trial. 11th IFMAD Conference 2011.

“I have been testing this in many ways. I tried going without Valkee for 5 days to see if there was a difference. I got immediately the migraine and restless legs back! I will not leave my Valkee anymore! THANKS! ”

-Feedback email to Valkee, Female 30 years

Ongoing and future Valkee research

Valkee’s research program combines three scientific approaches, as presented in the Table below. The program aims at thoroughly understanding how bright light via ear canal direct to brain affects our mood.

Table: Valkee’s research program progression

Brain biology Neuroimaging Clinical trials
Completed research Brain photosensitivity Brain response to light via ear canal Efficacy in Seasonal Affective Disorder
Ongoing research Hormone response Brain response in the depressed brain Jetlag, cognitive performance, migraine
Future research Neural signaling routes Other indication-specific responses Anxiety

 

“I just started Valkee again for this year. Kiss goodbye to SAD.”

-Valkee Facebook group member, Female

Mehr Infos und 

 

References

[1]Terman M, Terman JS. Controlled trial of naturalistic dawn simulation and negative air ionization for seasonal affective disorder. Am J Psychiatry 2006;163:2126-33.
[2] Eastman CI, Young MA, Fogg LF, Liu L, Meaden PM. Bright light treatment and winter depression. Arch Gen Psychiatry 1998;55:883-9.
[3] Ravindran AV, Lam RW, Filteau MJ, Lespérance F, Kennedy SH, Parikh SV, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults. V. Complementary and alternative medicine treatments. J Affect Disord 2009; 117 Suppl 1:S54-64.
[4] Drug and Therapeutics Bulletin. Clinical review. Management of seasonal affective disorder. BMJ 2010;340:c2135
[5] Avery DH, Eder DN, Bolte MA, Hellekson CJ, Dunner DL, Vitiello MV, Prinz PN. Dawn simulation and bright light in the treatment of SAD: a controlled study. Biol Psychiatry 2001;50:205-16.
[6] Campbell SS, Murphy PJ, Suhner AG. Extraocular phototransduction and circadian timing systems in vertebrates. Chronobiol Int 2001;18:137-72.
[7] Timonen M et al. Transcranial Brain-Targeted Bright Light Treatment via Ear Canals in Seasonal Affective Disorder (SAD). Poster presentation at the 11th IFMAD Conference 2011, November 9-10, and Jurvelin H et al. Transcranial Brain-Targeted Bright Light Treatment via Ear Canals in Seasonal Affective Disorder (SAD) – a Randomized Controlled Trial. Poster presentation at the 11th IFMAD Conference 2011, November 9-10
[8] Nissilä J et al. The Abundance and Distribution of the Encephalopsin (OPN3) in the Human Brain. Poster presentation at the Scandinavian Physiology Society Annual Meeting 2011, August 12-14.
[9] Elseoud A et al. Group-ICA Model Order Highlights Patterns of Functional Brain Connectivity. Front Syst Neurosci. 2011; 5: 37. Available online at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3109774/
[10] Starck T et al. Stimulating brain tissue with light – resting state fMRI analysis. Human Brain Mapping Conference 2009 & ISMRM Annual Conference 2011.
[11] Stein DJ, Baldwin DS, Baldinetti DS, Mandel F. Efficacy of pregabalin in depressive symptoms associated with generalized anxiety disorder: A pooled analysis of 6 studies. Eur neuropsychopharmacol 2008;18:422-30.
[12] Pande AC, Crockatt JG, Feltner DE, Janney CA, Smith WT, Weisler R, Londborg PD, Bielski RJ, Zimbroff DL, Davidson JR, Liu-Dumaw M. Pregabalin in generalized anxiety disorder: a placebo-controlled trial. Am J Psychiatry 2003;160:533-40.
[13] Feltner DE, Crockatt JG, Dubovsky SJ, Cohn CK, Shrivastava RK, Targum SD, Liu-Dumaw M, Carter CM, Pande AC. A randomized, double-blind, Placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder. J Clin Psychopharmacol 2003;23:240-9.
[14] Pohl RB, Feltner DE, Fieve RR, Pande AC. Efficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlledcomparison of BID versus TID dosing. J Clin Psychopharmacol 2005;25:151-8.
[15] Rynn M, Russell J, EricksonnJ, Detke MJ, Ball S, Dinkel J, Rickels K, Raskin J. Efficacy and safety of duloxetine in the treatment of generalized anxiety disorder: a flexible-dose, progressive-titration, placebo-controlled trial. Depress Anxiety 2008;25:182-9.
[16] Koponen H. Allgulander C, Erickson J, Dunayevich E, Pritchett Y, Detke MJ, Ball SG, Russell JM. Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians. Prim Care Companion J Clin Psychiatry 2007;9(2):100-7.
[17] Hartford J, Kornstein S, Liebowitz M, Piqott T, Russell J, Detke M, Walker D, Ball S, Dunayevich E, Dinkel J, Erickson J. Duloxetine as an SNRI treatment for generalized anxiety disorder: result from a placebo and active-controlled trial. Int Clin Psychopharmacol 2007;22(3):167-74.
[18] Nicolini H, Bakish D, Duanes H, Spann M, Erickson J, Hallberg C, Ball S, Sagman D, Russell JM. Improvement of psychic and somatic symptoms in adult patients with generalized anxiety disorder: examination from a duloxetine, venlaflaxine extended-release and placebo-controlled trial. Psychol Med 2009;39:267-76.

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