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(WTKR)   Suffer from migraines? The FDA has approved Geordi Laforge's visor as a treatment   (wtkr.com) divider line 21
    More: Spiffy, FDA, migraines, sewage treatment, evidence-based medicine, randomized controlled trials  
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1382 clicks; posted to Geek » on 13 Mar 2014 at 9:10 AM (20 weeks ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



21 Comments   (+0 »)
   
View Voting Results: Smartest and Funniest
 
2014-03-13 09:31:05 AM
I bet he didn't see that coming.
 
2014-03-13 09:34:16 AM
No, this isn't a visor, this is some sort of weird third eye psionics device. I'm sure there must be some relevant sci-fi somewhere but it is early and I am lazy.
 
2014-03-13 10:06:23 AM
A dark/cool room and 20 minutes is all I need.

Now, if only I could find one at the office.
 
2014-03-13 10:16:11 AM
So 38% had a 50% reduction in episodes with no effect on severity? With numbers that definitive, why bother with a control group?
I bet this is every bit as effective as a $250 placebo.
 
2014-03-13 10:20:45 AM
If you're having hull problems I feel sorry for you son, I got 99 Problems but breach ain't one.
 
2014-03-13 10:23:23 AM

Fano: If you're having hull problems I feel sorry for you son, I got 99 Problems but breach ain't one.


i1-news.softpedia-static.com
I can get jiggy wit' it

Also, kind of ironic, since Geordi's visor caused him constant headaches.
 
2014-03-13 10:23:30 AM
I am the first nerd to point out that the prop Levar Burton wore in TNG actually dug into the sides of his skull slightly and would routinely give him headaches.

Do I win anything other than an empty bed to sleep in tonight?
 
2014-03-13 10:24:07 AM

whosits_112: Fano: If you're having hull problems I feel sorry for you son, I got 99 Problems but breach ain't one.

[i1-news.softpedia-static.com image 305x225]
I can get jiggy wit' it

Also, kind of ironic, since Geordi's visor caused him constant headaches.


Curses, I don't even get first now! And still the empty bed!
 
2014-03-13 10:32:24 AM

Crotchrocket Slim: I am the first nerd to point out that the prop Levar Burton wore in TNG actually dug into the sides of his skull slightly and would routinely give him headaches.

Do I win anything other than an empty bed to sleep in tonight?


We can share. Levar got headaches from the prop, and as I mentioned, Geordi got headaches from the VISOR on the show. So, we both win!
 
2014-03-13 10:32:32 AM

SewerSquirrels: So 38% had a 50% reduction in episodes with no effect on severity? With numbers that definitive, why bother with a control group?
I bet this is every bit as effective as a $250 placebo.


I went looking for more information, from  http://www.nbcnews.com/health/health-news/fda-approves-new-device-pre v ent-migraines-n50331
"A 67-person study reviewed by the FDA showed patients using the device experienced fewer migraines per month than patients using a placebo device. The Cefaly headband did not completely eliminate migraine headaches or reduce the intensity of migraines that occurred. "

I've yet to find an article that actually talks about the study in real terms though, so I don't know if it was a randomized double blind or not.  And I don't have enough medspeak to read the original study.
 
2014-03-13 10:50:56 AM
This isn't a visor, you apply it directly to the forehead.
APPLY DIRECTLY TO THE FOREHEAD
APPLY DIRECTLY TO THE FOREHEAD.
 
2014-03-13 11:10:43 AM

whosits_112: Fano: If you're having hull problems I feel sorry for you son, I got 99 Problems but breach ain't one.

[i1-news.softpedia-static.com image 305x225]
I can get jiggy wit' it

Also, kind of ironic, since Geordi's visor caused him constant headaches.


came for this
 
2014-03-13 11:16:04 AM

pastorkius: This isn't a visor, you apply it directly to the forehead.
APPLY DIRECTLY TO THE FOREHEAD
APPLY DIRECTLY TO THE FOREHEAD.


Like this?

kwalee.com
 
2014-03-13 11:25:03 AM

turboke: pastorkius: This isn't a visor, you apply it directly to the forehead.
APPLY DIRECTLY TO THE FOREHEAD
APPLY DIRECTLY TO THE FOREHEAD.

Like this?

[kwalee.com image 500x328]


PICARD, APPLY DIRECTLY WITH A FACEPALM.
 
2014-03-13 11:38:15 AM

Unoriginal_Username: A dark/cool room and 20 minutes is all I need.

Now, if only I could find one at the office.


As an IT guy with migraines, I found the server room to be a perfect place. White noise, cold AC, and you can cut the lights off.

I recommend not looking at the drive lights blinking.
 
2014-03-13 11:38:28 AM

whosits_112: turboke: pastorkius: This isn't a visor, you apply it directly to the forehead.
APPLY DIRECTLY TO THE FOREHEAD
APPLY DIRECTLY TO THE FOREHEAD.

Like this?

[kwalee.com image 500x328]

PICARD, APPLY DIRECTLY WITH A FACEPALM.


Shaka, when the walls fell
 
2014-03-13 11:44:34 AM

russlar: whosits_112: turboke: pastorkius: This isn't a visor, you apply it directly to the forehead.
APPLY DIRECTLY TO THE FOREHEAD
APPLY DIRECTLY TO THE FOREHEAD.

Like this?

[kwalee.com image 500x328]

PICARD, APPLY DIRECTLY WITH A FACEPALM.

Shaka, when the walls fell



I was actually at their Tanagra show, way back in the day

31.media.tumblr.com
 
2014-03-13 12:24:46 PM
"Suffer from migraines?"

No, I enjoy them!
 
2014-03-13 12:38:08 PM

Running a-puck:
I've yet to find an article that actually talks about the study in real terms though, so I don't know if it was a randomized double blind or not. And I don't have enough medspeak to read the original study.


i.imgur.com

The patient population was small,and p=0.04 is right on the edge of significance, but it was double-blind, randomized, and had a sham/placebo, so it looks like they're doing it right.

Abstract from the PERMICE study, "Sixty-seven patients were randomized and included in the intention-to-treat analysis. Between run-in and third month of treatment, the mean number of migraine days decreased significantly in the verum (6.94 vs 4.88; p = 0.023), but not in the sham group (6.54 vs 6.22; p = 0.608). The 50% responder rate was significantly greater (p = 0.023) in the verum (38.1%) than in the sham group (12.1%). Monthly migraine attacks (p = 0.044), monthly headache days (p = 0.041), and monthly acute antimigraine drug intake (p = 0.007) were also significantly reduced in the verum but not in the sham group. There were no adverse events in either group."

There was an earlier study (VIGILANCE) that demonstrated a sedative effect, although they went for the migraine indication over the insomnia indication. Reasonable enough business decision. The device was launched in France in October 2012; it's only new to the US.

From the FDA's press release: "The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. [ ... ] The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium."

(The 2313-patient satisfaction study is also online; the tl;dr version of that study is that it confirmed safety, but not efficacy.)

The FDA is concerned with safety to the point of paranoia (in their defense, that's their job), so I speculate that it was as much the lack of SAEs in the European population that made the case for approval as it was the PERMICE study, combined with the observation (in PERMICE) that patients on the device reduced their use of antimigraine drugs (p=0.007) in a statistically significant manner; part of assessing risk versus benefit is that antimigraine medications have their own side effects. Reduce those by introducing a new a therapy that doesn't introduce more side effects than it eliminates, and the risk/reward balance tips in favor of approval.
 
2014-03-13 10:47:23 PM
Spent three hours.on the floor of my office today because of a migraine and couldn't see to drive home.

Make them stop please.
 
2014-03-14 06:20:05 AM

kim jong-un: Spent three hours.on the floor of my office today because of a migraine and couldn't see to drive home.

Make them stop please.


Considering the fact that I'm having a migraine right now, you have my sympathy.
 
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