FDA approved some new device to combat depression

[Bootless]

As far as I can tell, there has been only one clinical trial: Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial

I haven't read the whole thing but, 

A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95% confidence interval = 0.51–4.01, P = 0.012).

I'm no expert, but it seems like 9.41 v 7.14 placebo with a +or - of 6.1 error range isn't very good. It seems that any improvement falls within the range of error.

I wonder about the expertise and rigor at the current FDA. Did the approval board members get stock in the company?

----------
I've been seeing some weird advertisements on youtube lately, I will make a fake add now:

Oh you are lucky to see this add.
The medical industry doesn't want you to see this.

For $39.99 you will be given the secret method of ending depression.

It's all about the exact angle and distance at which to hold your cell phone while conversing.

It took me years to discover.
But for $39.99 you will get the secret that will save you years of trial and error.

Act now, before this ad gets removed.

[ this is a fake ad, used for educational purposes only ] 

[Moon68]

Didn't Kurt Cobain pioneer at home depression treaments?

[PorkChop96]

Didn't Kurt Cobain pioneer at home depression treaments?

[Image: https://denyignorance.com/uploader/image...121c85.png]

[Rubyred356]

Didn't Kurt Cobain pioneer at home depression treaments?

[Image: https://denyignorance.com/uploader/image...121c85.png]

I believe he committed suicide or was killed. Not sure and also don't care. That's just hippie music designed to cause disruption. If he pioneered something I want no part of it.

[PorkChop96]

I believe he committed suicide or was killed. Not sure and also don't care. That's just hippie music designed to cause disruption. If he pioneered something I want no part of it.

That was the joke.......


It's not that serious man

[Rubyred356]

That was the joke.......


It's not that serious man

Forgive my misunderstanding. Good joke I must say!

[andy06shake]

I believe he committed suicide or was killed. Not sure and also don't care. That's just hippie music designed to cause disruption. If he pioneered something I want no part of it.

I loved "Nirvana."

Nirvana played Grunge music, not what one would call stereotypical "hippie music." 

Nirvana helped pioneer and popularise the genre, taking it regional, from a mere underground sound.

The man had issues, but he also had skills....

[Encia22]

This device is named Flow's FL-100.
This is a at home device that in some technical way will push some kind of wireless signals to the brain to assist with the mitigation of depression.

I can't figure how to make a direct link to the Reuters article I just read. But apparently this will be the new norm,  for better or worse this is the reality we love in.

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[Maxmars]

The deeply hurtful time when I learned of and was made to endure this transcranial EM therapy to combat a sleeping disorder...it did nothing, helped not at all, and they never even called to ask "how I was doing."

30 consecutive days of this therapy was intended to 'force' my brain to circumvent the "signal blockage" induced by sparking high intensity magnetic fields in my brain.. forging new pathways that allow for a different pathway to become dominant... preferred... and "hopefully" better than before....

It's not that I can say it doesn't work, perhaps it really helps... it did not only not help me... but I had the worst flare up of anxiety and sleeplessness that I had ever experienced in my life.  These things are never perfect, and each patient must be able to give feedback....

In my case, after the contracted operation subjected me to the process (not bad or painful) I referred to my persistence of symptoms, and the technicians were very nice and kind...but they always told me to give it time to work, and to tell the doctor when they call... they never called....

I spoke to the office to let them know...and they told me a doctor would call... never happened.

So whatever money was exchanged for the service... was spent and payed... so the company providing the service disappeared into the night... gone now.... and that's no one's problem but my own.

NOW these new "toy' versions are on the market.... and I can't wait the hear the consumer responses once the late-night TV starts selling them for 99.99 a month for eight months....  Gotta love medicine as a profit making industry.... noice.

[quintessentone]

The deeply hurtful time when I learned of and was made to endure this transcranial EM therapy to combat a sleeping disorder...it did nothing, helped not at all, and they never even called to ask "how I was doing."

30 consecutive days of this therapy was intended to 'force' my brain to circumvent the "signal blockage" induced by sparking high intensity magnetic fields in my brain.. forging new pathways that allow for a different pathway to become dominant... preferred... and "hopefully" better than before....

It's not that I can say it doesn't work, perhaps it really helps... it did not only not help me... but I had the worst flare up of anxiety and sleeplessness that I had ever experienced in my life.  These things are never perfect, and each patient must be able to give feedback....

In my case, after the contracted operation subjected me to the process (not bad or painful) I referred to my persistence of symptoms, and the technicians were very nice and kind...but they always told me to give it time to work, and to tell the doctor when they call... they never called....

I spoke to the office to let them know...and they told me a doctor would call... never happened.

So whatever money was exchanged for the service... was spent and payed... so the company providing the service disappeared into the night... gone now.... and that's no one's problem but my own.

NOW these new "toy' versions are one the market.... and I can't wait the hear the consumer responses once the late-night TV starts selling them for 99.99 a month for eight months....  Gotta love medicine as a profit making industry.... noice.

I'm sorry you had to suffer through that, I can't imagine not being able to sleep restfully. But are the electrodes attached to the same areas of the brain for sleep issues vs. depression issues? Maybe there is more science to learn about this device.