Valkee has released new evidence for their depression combating earlights

Kuko 4000

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Kuko 4000
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Here's the latest:

http://www.arcticstartup.com/2011/05/30/valkee-releases-scientific-evidence-to-show-proof

Valkee's brain stimulation headset is based on new findings in brain science and bright light therapy. It has been studied since 2007 in the University of Oulu, Finland, by approximately 20 scientists cross-functionally in neurobiology, psychiatry and brain biology. In total, research has included over 350 study subjects, making it one of world's largest programs in bright light research.

Valkee's research has concluded the following:

The human brain is photosensitive
Valkee causes activity in the brain through the ear canal
Valkee is an effective way to increase energy and cognitive performance, reduce anxiety and treat mood disorders, especially seasonal depression
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Here's the new PDF:

http://www.valkee.com/uk/Valkee_Poster_Presentation-Human_Brain_Photosensitiveness_May2011.pdf

Update 30th May, 2011: Timo Ahopelto, one of the investors working with Valkee has posted and corrected the sentence we've striked out: "The current paper that Valkee released is a presentation from the ISMRM Annual Conference 2011 in Montreal. Science presented this way is reviewed, and a standard practice in medicine to start with presentation, to be followed with article."
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Does anyone know more about the conference? Here's their website:

http://www.ismrm.org/11/


Valkee has also updated their website:

http://www.valkee.com/uk/science.html#navigation


From the beginning this has raised some interesting questions to me because Valkee has started selling the device in pharmacies and all kinds of normal stores before having any reasonable scientific evidence to show its efficacy. And with a good price too: 185 euros :boggled:

Interesting to see what comes out of this...
 
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Yeah, so they probably has a poster is a convention hall, can be reviewed does not mean will be and the article will likely never be published...

In fact looking at the ISNRM web site I doubt they wopuld support such crap...

the presntation poster is interesting but I really have to wonder

This:
http://www.edoctoronline.com/medical-atlas.asp?c=4&id=21676&m=1&p=8&cid=1048&s=

makes me wonder as there is about as much if not more bone tissue as there is in the cranial skull bones.

So what ever photic stimulation there is, is of the ear tissue itself, not the brain.

I could be totally wrong.
 
Geez, what kind of open minds do you guys have here if a guy comes up with photo-receptive light therapy, and you tell him to stick it in his hear? ;)

Ever notice that those Finns sure do a lot of leading edge science, for such a little country? They sure must have some fantastic education system to come with all that science!
 
But there's no connection between the ear canal and the brain. If there was, those water jet ear cleaners I've been using would have killed me by now.

If high pressure water can't get to my brain through my ear, light can't either. Who could think this works?
 
ehcks said:
But there's no connection between the ear canal and the brain. If there was, those water jet ear cleaners I've been using would have killed me by now.

If high pressure water can't get to my brain through my ear, light can't either. Who could think this works?
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Something can be waterproof and still be translucent... Think of putting a bright flashlight under your palm and looking through the top of your hand.

(I'm not promoting the functionally or lack there-of of the the product in the OP.)

I somewhat remember some study that light levels (not just those detected by the eyes) can affect sleep patterns. (If I remember correctly a sufficient blind fold was used and temperature of the room was controlled.) Unfortunately I don't remember where/how the body was detecting the light level, or if it was even determined.
 
OTT, I had thought the study mentioned that light has to strike behind the knee? Seems it was a SAD study, IIRC ? Or was it a jet lag study on re-setting your circadian rhythm?

But hmmmm, to get natural light to shine into your ear, you would need to be up and about. Perhaps we are evolved to become depressed without such activity? Could it be to conserve energy during inclement conditions? Night, storms, winter? So, depression is 'natural and beneficial' in normal amounts?
 
casebro said:
OTT, I had thought the study mentioned that light has to strike behind the knee? Seems it was a SAD study, IIRC ? Or was it a jet lag study on re-setting your circadian rhythm?
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Light therapy involving knee not effective
BOSTON, MASSACHUSETTS. In January 1998 researchers at Cornell University reported a major discovery that could be of significant benefit to patients with seasonal affective disorder (SAD).
(...)
Now researchers at the Harvard Medical School report that they have been unable to repeat the findings observed by the Cornell researchers.
(...)
Wright, Kenneth P. and Czeisler, Charles A. Absence of circadian phase resetting response to bright light behind the knees. Science, Vol. 297, July 26, 2002, p. 571
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http://www.yourhealthbase.com/database/a129a.htm
 
Perhaps somebody conflated the old cartoon of a light bulb over your head to mean an idea? "Bright" meaning cheery, vs "Dark" meaning depressed? So, a bright light ought to combat depression? It makes just as much sense to be salable to the ignorant.
 
From The Telegraph:

http://www.telegraph.co.uk/health/h...d-in-the-ear-for-those-with-winter-blues.html

However, now scientists have come up with a new way of tackling seasonal affective disorder (SAD), that they say cures it in just eight minutes a day.

The technique involves beaming light directly into the brain through the ears.

It is based on the discovery that the brain itself is just as sensitive to daylight as the eyes, with 'photoreceptive' parts using it to help set our biological clocks.
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Ok, this is getting international coverage now, could someone take a closer look at the studies Valkee quotes:

Transcranial Bright Light Treatment via Ear Canals in Seasonal Affective Disorder (SAD) – a Randomized Controlled Trial

http://www.valkee.com/uk/Transcranial_Bright_Light_Treatment-IFMAD.pdf

Figure 1 seems to show an effect, but on Figure 2, it seems to me that the dose of 1 lumen works better than the dose of 9, but the dose of 4 lumen works better than both. I'd like to know what they hypothesized before the test. Why wasn't there a dose of 0 as a better placebo?


This seems similar to me, but I can't see the results anywhere:

Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study

http://clinicaltrials.gov/ct2/show/study/NCT01293409

Placebo: Placebo Comparator
The amount of photic energy of light is considered to be non-therapeutical
Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE

Intermediate dose: Experimental
The amount of photic energy of bright light is considered to be "intermediate"
Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE

High dose bright light: Experimental
The amount of photic energy of bright light is considered to be fully therapeutic
Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE
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If these two are the same study it seems to me that their results don't quite match the expectations. But I don't know for sure and I might just be misreading the graphs. Anyone?

Here's the evidence page of Valkee's website: http://www.valkee.com/uk/science.html#navigation
 
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Why was "placebo controlled" removed from trial?

Some facts:
There are two versions of the trial (id=NCT01293409) on clinicalTrials.gov. The initial 2011.02.09 version lists "placebo controlled" as a design element. The second and final version from 2011.05.31, contains the results of the study. That final version also seems to have had the "placebo controlled" element deleted. (See "History of Changes" at clinicalTrials.gov)

The NCT01293409 trial was described as having three groups (Placebo, Intermediate dose, High dose) with an estimated enrollment of 90.

On the Valkee site, the clinical trial is described as follows: "During the four-week study period 89 subjects suffering from SAD received 12-min daily doses of photic energy in three different randomly divided groups (1, 4, 9 lumen)."

Some speculation:
The clinical trial referred to by Valkee seems to be NCT01293409. However in the Valkee study the placebo group has disappeared and has become the '1 lumen' treatment group.

Could it be that Valkee ran the study originally using a placebo group but the actual results showed that even the placebo group elicited a strong response? Indeed as noted above by Kuko 4000 the 1-lumen group outperforms the 9-lumen group.

Faced with these results could Valkee have decided that the 1-lumen light level was not a placebo but was sufficient to cause an improvement in symptoms of SAD? So the placebo group was re-classified as a treatment group?

It may be true that the 1-lumen light has a genuine non-placebo effect. But it may equally be true that none of the three levels of light (1, 4, 9-lumens) has a genuine (non-placebo) effect and all results are due solely to the placebo effect. Having no placebo group, how can Valkee be sure as to what is going on in their study? The improvement in SAD may be real but Valkee cannot exclude that this is due to the placebo effect.

And the placebo effect may be very strong here given that a previous study had shown a biological effect on the brain triggered by light fed in through the ears and confirmed using fMRI (assuming that the trial volunteers were told about this study when recruited)
 
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