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Does anyone have any experience with the newly approved FDA Appliance for cluster headaches the "Gammacore?" It looks like  a cordless shaver and you apply it to the vagus nerve and it has had significant impact on cluster headaches, in trial. I looked into it and it was not due to be released in America until the third quarter, which is technically now. It looked as if the cost was going to be around $500. I talked to somebody in England with the manufacturer who said that yes it would be around $500 but that would be $500 a month! I mean who could possibly afford that? Anyway I just want to hear from the Cluster Buster folks.

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I don't know about the cost.  You can see clinical trial results here: https://gammacore.us/clinical-studies/    It doesn't look like a very good alternative to oxygen to me, unless O2 doesn't work for you (but O2 works for almost everyone when set up and used properly).  Portability is of course a significant advantage over O2.  Useless for chronic CH, it appears.  I remember that one study suggested that it had some preventive effect regarding subsequent attacks.  If that's true, it would be an advantage over oxygen.

I always feel like I should add this to any discussion of Gammacore: In the clinical trials, some people got placebos (fake devices).  That is a heck of a commitment, to agree that you might be enduring attacks with something that won't help you at all.  My appreciation and admiration for the people who volunteered to do that is enormous.

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I appreciate the response to this topic. I'm hoping that if $500 a month can be gotten for this vagus nerve stimulator then somebody else may come up with alternative devices to stimulate the same nerve for similar results. I'm still in shock over the $500 a month cost. I've put myself on the list to be notified when it's actually available here in America but I haven't heard from them to that effect, yet. I will post it when I do.

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I spoke with the folks at gammaCore today (7/19/17). The cost is $575 per month and is not (so far) covered by insurance. Your physician can sign up at www.gammacore.com and prescribe the device for you. There is a specialty pharmacy involved and once your authorization and payment is in place it's sent to you within 2 days.

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I was at my neuro's office on Thursday, the gammacore representative was there to demonstrate the device and answer questions for the doc's, I sat in. I'm not sure the positives for the device outweigh the negatives, but the fact that something new can be added to our arsenal of weapons to fight the beast has to be a good thing. I tried it, feels like small electrical pulse on your neck, while that is going on, the corner of your mouth droops a little.

Positives:

1. Portable, looks like a 2 headed electric razor, sounds like it also.

2. No evasive surgical implant.

3. No side effects (droopy mouth, stops when turned off)

4. No problem with TSA.

5. Shelf life is 18 months, if not turned on, not sure how long it is if turned on.

Negatives:

1. Cost, $575, about 300 "doses" (if it is used up before 30 days, you can a "refill" for free), since this is new to USA, the manufacturer is offering $100 off,   and I believe the rep. said the first 2 months are free if you are in the registry.

 2. It works only for episodics, and only 47% of the CHer's tested (aborting the CH). There was no data on whether it helped the other 53%, they only measured aborting the CH. The ultimate goal is to expand it to work with migraine patients. 

They base the usage on a 30 calendar, once you turn it on, they start counting.

Their representatives with be in Chicago for our conference in Sept.

They are looking for approval for the 2nd generation model, which looks like a cell phone, and has a shelf life of 5 years, The rep. did not know that cost.

I hope I remembered this correctly, a lot was going on. I know this does not answer all the questions.

 

 

 

 

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7 hours ago, zgreek said:

I was at my neuro's office on Thursday, the gammacore representative was there to demonstrate the device and answer questions for the doc's, I sat in. I'm not sure the positives for the device outweigh the negatives, but the fact that something new can be added to our arsenal of weapons to fight the beast has to be a good thing. I tried it, feels like small electrical pulse on your neck, while that is going on, the corner of your mouth droops a little.

Positives:

1. Portable, looks like a 2 headed electric razor, sounds like it also.

2. No evasive surgical implant.

3. No side effects (droopy mouth, stops when turned off)

4. No problem with TSA.

5. Shelf life is 18 months, if not turned on, not sure how long it is if turned on.

Negatives:

1. Cost, $575, about 300 "doses" (if it is used up before 30 days, you can a "refill" for free), since this is new to USA, the manufacturer is offering $100 off,   and I believe the rep. said the first 2 months are free if you are in the registry.

 2. It works only for episodics, and only 47% of the CHer's tested (aborting the CH). There was no data on whether it helped the other 53%, they only measured aborting the CH. The ultimate goal is to expand it to work with migraine patients. 

They base the usage on a 30 calendar, once you turn it on, they start counting.

Their representatives with be in Chicago for our conference in Sept.

They are looking for approval for the 2nd generation model, which looks like a cell phone, and has a shelf life of 5 years, The rep. did not know that cost.

I hope I remembered this correctly, a lot was going on. I know this does not answer all the questions.

 

 

 

 

5 hours ago, urs said:

Well...

Short cirquit 3 AAA batteries, hold it a sec to your neck and you are done!

Wy the hell nobody realizeses this huge scam, damm...

 

WACKE UP GUYS, DON'T BE SO DAM STUPID!!!

On 7/19/2017 at 5:22 PM, urs said:

Padre 

if you have success abording an attack by massaging the vagnus nerve at the neck I guess the gammacore may be of use if not, I would wait for others confirming so you dońt loose the money!

I appreciate the response to this topic. I'm hoping that if $500 a month can be gotten for this vagus nerve stimulator then somebody else may come up with alternative devices to stimulate the same nerve for similar results. I'm still in shock over the $500 a month cost. I've put myself on the list to be notified when it's actually available here in America but I haven't heard from them to that effect, yet. I will post it when I do.

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I appreciate all of the information in response to this post. There is still much to be learned about the gammacore. I don't know that the stimulation to the vagus nerve is electrical or if it's Sonic. I'm not an electrical engineer. Neither am I stupid. I do know how to spell. Keep the discussion going. Thanks, again

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I'm sorry for my outburst and I did not want to offend anybody padre. I was telling it in a general manner out to the people out there.

The whole setup of cammacore is just done to work nicely.

Developed for migraine ...  
 

Guess what it really is? It can't be sophisticated at all or it would need restricted permission to be sold, bought or used. The gammacore does not have any government based certificate this unit being useful to do whatever it claims to be able to do. The onliest thing one can be sure of is the fact this unit won't harm you when used as described in the manual.


;)

 

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Apology accepted. I don't doubt that the gammacore distributor has Serious predatory inclinations. The FDA release must mean something. Short-circuiting three Triple-A batteries to duplicate gammacore's effect sounds untested. Massaging the vagus nerve has had no benefit for me. Thanks again for your interest.

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Sevral neurostimulator are on the market. In first place for migraene. Gammacore claims to lower CH frequency by 50% or so and should even be able to abort an attack.

Gammacore original from europe 2011/12 turned out to be just USLESS for us. All positive threads do end after just 2-3 entries. People saying the unit may be successfull for the very first days just do turn rapid a usless junk!

In all forums I've checked so far one can't find not one CH using this unit on a continuing base.

Often called bullshit be whom tested...

None of those units do any good to us. imagen gammacore beeing on your the market approx. 15 years and this site did not report anything about this unit.

Or is it somebody beliving european CH are hidding a successfull treatment.

Another unit called visto, same shit to us.

A huge dam fu.. scam. Be aware before flushing a couple of 100 usd/month down the hill.

What makes me especially sad is the fact people trying get profit ou off our pain. Yes I do call them assholes. If needed I'll confirm the assh... written!

Thete are enough challenges in live. I do not need such people never ever

:(:(:( 

Urs

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I agree that the parasitic predators that depend upon people's ill health to exorbitantly profit are very low. I appreciate all your research on the subject and it definitely makes me pause almost as much as the $500 a month makes me pause. Actually $500 a month just keeps me away from it totally. One notion that I have in the back of my assessment of this is that when I showed the medical journal article to my neurologist that specializes in headaches she told me that the lead researcher of the panel who led the FDA approval was her Mentor back when and that she had complete confidence in him. Never the less, I'm not rushing into this by any means and it does sound like there's a large possibility that these guys are scamming us. Thanks again for your research and for relaying it. I apologize for any typos that might be in this message but it's late I'm tired and I do not have the patience to try to edit these little windows.

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I have used the Gammacore for the last month and it works great as a preventative treatment for me, I use it for 4 minutes twice a day.

I paid $598 for the gammacore device that has 300 two minute sessions and a 30 day shutoff timer that shuts off the device after 30 days of use (or non-use.)

Once activated the gammacore expires in 30 days, I used it 90 times in a month so 300 uses is more than enough for anyone in a month.

I also underwent Botox for a year prior but the side effects of Botox were too much for me so I prefer the gammacore.

I am a retired Electrical Electrical Engineer that served on a nuclear submarine so I know a little about acoustical energy, I took the gammacore apart and the 2 silver round electrodes on top  are actually sonic transducers that emit sound waves -  NOT electrical waves.  Underneath the electrodes are two clear plastic balls filled with a gel in which the sound wave is transmitted into the vagus nerve.  2 electrode screws are inserted into the gel to transmit the sound energy and the frequency is adjustable.

This stimulation of the vagus nerve is by sound, quite similar to the Yoga chant "oooohhhhmmmm" that also can vibrate the vagus nerve slightly while the gammacore can REALLY vibrate the vagus nerve!

The Gammacore is powered by 2 three volt batteries in parallel so if you know what you are doing you can "bypass" the 30 day shutoff timer and use the single gammacore for months and save thousands.  You will need a couple electrical jumpers and a small rheostat to adjust the sound frequency, can get at radioshack for $5 bucks.

I will post the detailed instructions and photos as to how to bypass the gammacore timer and have a permanent device, I cannot recommend this for novices due to safety risks and always wear eye protection when working around batteries.

And I predict gammacore will start selling a permanent gammacore device soon, $598 a month is ABSURD!

 

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Thanks, 'bob!   I'm just curious about what it means when you say it works great as a preventive.  I had noticed in the clinical trial results that it seemed to have some efficacy as a preventive (for people who were episodic but not chronic, as I recall). What level of prevention are you experiencing?  Are you also using it as an abortive for attacks (if there are any) that are not prevented?  How long have you had CH and what's your typical cycle like?  Had you used pharma preventives previously?  Doing the D3 regimen?  

A lot of questions, which of course you're not obliged to answer.  Any input to help me/us weigh this substantial expenditure would be appreciated.

 

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I used the gammacore as an abortive treatment perhaps 4 times while also using it primarily as a preventative treatment, in all cases it worked just fine and stopped an active attack in about a minute.

I've suffered from episodic CH since 2004. I have a complex etiology with cervicogenic injuries and advanced osteoporosis, too complex for this chat room, I am a  one in 20 million patient with rare and complex injuries resulting from trauma.

I take 160,000 IUs of D3 monthly for bone density and do not see a reduction in CH from D3 intake.  Too much D3 can destroy your kidneys so you should be monitored closely if taking more than 100,000 IUs of monthly D3 supplements.

When you buy the gammacore you own it outright and can modify it however you wish, they only guarantee it for 30 days of consecutive use once activated and you must activate it within one year or it expires.

The gammacore is not "rocket science," but rather a simple device with 35 individual rheostats on a circuit board that make it look crowded inside.  Very simple to bypass the timer shutoff and use manually with an external rheostat device, similar to  light switch dimmer, just connect the batteries directly to the transducer electrodes and put the rheostat in-line, drill a small side hole for the wires and reseal the gammacore.

By the way, you can't post pics on this board, 0.49 mb is way too small of a limit or I would post the gammacore internal pics.

 

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On 10/4/2017 at 7:52 PM, spinebob said:

By the way, you can't post pics on this board, 0.49 mb is way too small of a limit or I would post the gammacore internal pics.

 

2

Sent you a message regarding the pics of the internals of the device. I'd like to see them and the information you have on extending its use.

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On 7/4/2017 at 1:40 PM, padre said:

Does anyone have any experience with the newly approved FDA Appliance for cluster headaches the "Gammacore?" It looks like  a cordless shaver and you apply it to the vagus nerve and it has had significant impact on cluster headaches, in trial. I looked into it and it was not due to be released in America until the third quarter, which is technically now. It looked as if the cost was going to be around $500. I talked to somebody in England with the manufacturer who said that yes it would be around $500 but that would be $500 a month! I mean who could possibly afford that? Anyway I just want to hear from the Cluster Buster folks.

I am due to get my free two month trial on Friday: 2 - 31 day supply or 2- 300 doses, whichever comes first.  Insurance probably won't cover anything after that.  Cost to purchase, with Discount is 498.00  for 31 days or 300 doses.  I will see how it goes, and keep you all posted!

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I tried Gammacore for a month for $498.00 (yes, it's $498.00 per month and it shuts off by itself on the last day and insurance will not pay). I found the device to be totally useless. I consider it as over-priced snake oil.  I am chronic, but I don't think that would matter. I find that sumatriptan injections and oxygen are the only abortives that work for me. Nothing works as a prophylactic  for me and I've tried nearly every med that you can think of. Sorry if I burst your bubble.

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Thank you for this, Cudahy'.  Very very mixed reviews on this device.  I did notice from the clinical trial reports that it was in fact useless or nearly useless for people with chronic CH, but more effective for episodics.

Have you tried the vitamin D3 regimen, which has worked well prophylactically for a very large percentage of the many people who have tried it, including many with chronic CH?  http://www.vitamindwiki.com/tiki-download_wiki_attachment.php?attId=7708

Are you able to have success with split sumatriptan injections?  Most people seem to need only 2 or 3mg, not the full 6 in the standard autoinjector typically prescribed for CH.  https://clusterbusters.org/forums/topic/2446-extending-imitrex/

 

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I'm going to try the vitamin D3 regimen. I read the referenced "paper" on the topic. The best that I can say for this paper is that it demonstrates that, anecdotally, someone had success pursuing it. The unfortunate thing, I feel, is that it's dressed up as a scientific paper, a peer reviewed study. It is none of those things. The author is not an Md. He is not an expert in nutrition or cluster headaches or medicine. All sorts of things such as fighter pilot, chemistry degree (B.S.? asdociates?) experience with oxygen and patent holder and such are trotted out as points to support the author's credence when in fact they have no bearing on the thesis.  Conversely,  would one want to hear a medical doctors dissertation on fighter planes? To reiterate I believe that it muddles rather than clarifies understanding cluster headaches to dress up an anecdote as a scientific paper.

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