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Anyone else in the GammaCore trials? (Read 5750 times)
MarkG253
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Anyone else in the GammaCore trials?
Dec 23rd, 2013 at 12:30pm
 
Hi, Is anyone else on here in the clinical trial for the GammaCore device?  If so, how are you making out so far?  I end the 1st phase today, with no luck yet.  I'm hoping I got the sham device for this phase.  I get a guaranteed working device tomorrow
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mjkbmw
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Re: Anyone else in the GammaCore trials?
Reply #1 - Dec 26th, 2013 at 5:55pm
 
I just finished the 1st round and received the activated device. I had no relief with the 1st device, so far I've treated once with the new device and I never got a full blown headache but that just may be a coincidence.
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Imitrex4Breakfast
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Re: Anyone else in the GammaCore trials?
Reply #2 - Dec 27th, 2013 at 5:23am
 
Please keep us updated. I'm very interested in hearing straight from a clinical patient if it works at all or not. I don't put much faith into published studies as they ALWAYS want more $$ for 'further studies'.

Thanks in advanced !

I4B

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Skyhawk5
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Re: Anyone else in the GammaCore trials?
Reply #3 - Dec 29th, 2013 at 12:03am
 
I'm currently in Phase 2 and finding no help from the device, in fact it seemed to trigger a Kip-9 the last time I used it.

Hope you have better results. I was told by the Nurse that Chronics are not doing well with the device.

Don
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Though I walk through the valley of the shadow of the Beast , I  have O2 so I fear him not.
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CH Brain
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Re: Anyone else in the GammaCore trials?
Reply #4 - Dec 31st, 2013 at 9:51am
 
My specialist has had one sitting on his desk for 6 months waiting for me to try. We can run a well supervised one man clinical trial model and draft a case study in me - as a single patient.
Not an official Gammacore clinical trial, but it's there if I want to try it. I have not tried it yet, because I just don't think it will work. Risk vs benefit cannot be accurately assessed until more data is collected.

My opinion:
Must admit, I am reluctant to deal with a medical device company that makes a device that administers a finite number of "doses" of an electrical pulse, without making the device rechargeable, reusable, recyclable.

I question the ethics (in our condition) of pre-designed obsolescence in electronics manufacturer's terms, with a carefully crafted "cost per abort", just below that of oral Sumatriptan (In Australia anyway). I've thoroughly inspected the patent drawings, designs and literature.

I can see no reason why any internal components would have any wear, or become unstable. Rather than have the unit designed for use to a calculated "end of life", it would be so easy to have this unit last 20 years, using inductive coupling charging systems, like those found on your $20 electric toothbrush - and the SPG implant...

But it's the Sunbeam toaster story all over again...sell more units, repeat customers...

In my view, I see a big marketing push and to me it seems, some potential conflicts of interest between study author's, investor's interests and principal investigators behind this one too.

If anyone wants a dossier on this device, let me know, I've gathered a fairly extensive collection of the available data on this device. I will post links here, if asked.

To the OP, sorry I'm not much help here, unless I go into clinic and have my training, supervision and follow up with the unit. Perhaps my thorough investigation of the unit and subsequent decision to tough out the CH attacks, rather than risk this device, is feedback on the device, in a way.

My 2 cents...

Cheers, Ben.
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Mike NZ
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Re: Anyone else in the GammaCore trials?
Reply #5 - Dec 31st, 2013 at 2:58pm
 
Quote:
Must admit, I am reluctant to deal with a medical device company that makes a device that administers a finite number of "doses" of an electrical pulse, without making the device rechargeable, reusable, recyclable.

I question the ethics (in our condition) of pre-designed obsolescence in electronics manufacturer's terms, with a carefully crafted "cost per abort", just below that of oral Sumatriptan (In Australia anyway). I've thoroughly inspected the patent drawings, designs and literature.

I can see no reason why any internal components would have any wear, or become unstable. Rather than have the unit designed for use to a calculated "end of life", it would be so easy to have this unit last 20 years, using inductive coupling charging systems, like those found on your $20 electric toothbrush - and the SPG implant...


I wonder how hard it would be to take the unit apart and recharge it?

I also suspect that from a design perspective making the battery over a year whilst retaining its charge is more complex than simply using a rechargeable battery. The rechargeable route is simple enough with either the ability to plug the device into a charger (just like I can with my phone, shaver, etc.) or use removeable batteries like my camera, headphones, mouse, tv remotes, etc. that can be either rechargeable batteries or not.

I know that if I was designing such a device then a key design consideration would be for it to be able to use commercial off the shelf batteries such as AA, PP3 or similar that are available worldwide in every kind of shop from supermarkets to petrol stations. I'd not want anyone with CH to ever be in a position that they could not abort a CH due to their battery being flat.
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MarkG253
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Re: Anyone else in the GammaCore trials?
Reply #6 - Jan 3rd, 2014 at 9:17am
 
Just an update...... Unfortunately, no relief with the 2nd phase of the trial for me..... Sad
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CH Brain
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Re: Anyone else in the GammaCore trials?
Reply #7 - Jan 29th, 2014 at 4:55pm
 
Hi to Mike and all,

Apologies to readers for the overly technical post.
But the device is by nature, technical.

I don't think battery life, or failure is the issue here. A draining or declining battery would create reliability issues with delivery of "doses" if it were to drain below usable voltage and current delivery at all.

From the Electrocore patent sheet:
Quote:
[0031] Current passing through an electrode may be about 0.01 to 40 mA, With voltage across the electrodes of 0.01 to 30 volts. The current is passed through the electrodes in bursts of pulses. There may be 1 to 20 pulses per burst, preferably five pulses. Each pulse Within a burst has a duration of 20 to 1000 microseconds, preferably 200 microseconds. A burst followed by a silent inter-burst interval repeats at 1 to 5000 bursts per second (bps), preferably at 15-50 bps.


In the clinical trial information on the Gammacore site, "Doses" delivered were 90 second duration and the device delivers 150 of them. At allowable current delivery for such an application, taking into account the total resistivity, required voltage and current drain, I would hardly call that "Heavy duty" battery drain.

An interesting post containing an email to a site user in Oz from an Oz Gammacore rep, back in 2011:

Quote:
This is a copy of the email i received from electrocore in australia.

Dear David,
Thank you for the email. I am pleased to report that we have recently received TGA approval for the gammaCore device and as such would be happy to work with you in your efforts to see if nVNS therapy works for your condition. Can you please advise if you are currently seeing a neurologist or pain management specialist. If so the first step would be for us to contact them to inform them of the devices TGA approval, and if they deem you to be an appropriate candidate, we would be delighted to provide you with a trial device.
I look forward to hearing from you.
Best regards,

Jeff Reid
Chief Executive Officer
jeff.reid@electrocoremedical.com.au

The device sells for $440 and is limited to 150 doses, and if my calculator is correct that's just under $3 per dose. which is less expensive than a lot of medications out there, and much more portable than O2. you can view the website here Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to Login or Register


The device delivers an exact number of doses - according to David here - 150 of them, which surely means that the device is counting them.

Just like printer ink cartridges, or sometimes printers themselves. I have seen a few printer designs where page counts determine "end of life" in a printer that would otherwise last years. This gave rise to end users hacking EEPROM (Electrically Erasable Programmable Read-Only Memory) chips themselves, which do the memorising, so as to bypass the programmed "end of life" time-span set up my manufacturers.

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From the Electocore parent; US20130131746 A1
See here for drawings, a PDF if you want one and device details:

(Note: The battery is not pictured, nor made reference to in terms of type, rated mAh, expected life, current delivery or voltage)

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From the Electrocore patent paper:
Quote:
The first truly functional, wearable pacemaker appeared in 1957, and in 1960, the first fully implantable pacemaker was developed.

Around this time, it was also found that electrical leads could be connected to the heart through veins, which eliminated the need to open the chest cavity and attach the lead to the heart wall. In 1975 the introduction of the lithium-iodide battery prolonged the battery life of a pacemaker from a few months to more than a decade.


I know battery technology has come a long way since 1975, to say the least. I was born that year. Since adulthood I have soldered in hundreds of different and superior batteries for differing end-use-applications, in 20 years of electronics manufacturing.

I would suggest that we are looking at a fairly basic CMOS counter "circuit" and EEPROM that decides for us exactly when our device will reach "throw away" status. From what I can work out, there is no user interface (like a display, readout, or USB port) that allows user reading of the number of doses already delivered. That could leave one in a nasty spot, should one actually find the device "effective" and begin to rely on it...

Given all that, I would say the device design is a quite deliberate and calculated attempt to target a deep-niche market with a product that users will come to "need" and be willing to pay for to replace, lest their CH should return.
IMO, unethical.

As we all know too well here, many a "decision" or "choice" has been made under the duress of severe and chronic CH.

I've been involved in proof-of-concept, manufacturing trial runs and have discussed the ethics and safety of devices made in different industries whilst working with electronics manufacturers.

I sincerely believe that those behind the Electrocore device believe in it's potential to help us. How many of those developers actually have CH, or have used the device?

I would say "let the trials speak for themselves", but the success rates reported anecdotally here and on other forums do not match the reported success rates in trial literature.

It smells fishy to me... battery life in this end-use-application, I suspect, has very little to do with the device becoming unusable. I think it is programmed to end.

Cheers, Ben.
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merle
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Re: Anyone else in the GammaCore trials?
Reply #8 - Mar 9th, 2018 at 6:11pm
 
HI any updates on the GammaCore? I am 55 and still getting CH- seriously, when do they end!! I havent had any for 3 years, and BOOM out of the blue they hit again- I live in Colorado and my doc, is in Chicago, Dr Robbins- I decided to try a new doc in CO, since easier to get to an they can get me the device monday AM- I am going to try it anything is better then imitex shots, and all the other meds.
I do live in COlorado, so med marijauna is here, but not sure its helped people? thanks for thoughts on the gammacore- I will get 1 month for free-
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trsixy
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Re: Anyone else in the GammaCore trials?
Reply #9 - Jan 9th, 2019 at 10:52am
 
I tried the gamma core  FREE? Trial back in February 2018, just one device for a month. Didn't work for me. Last week, January 2019 they sent a bill to my insurance for $1760.  They denied it of course. Couple hours of phone calls later I think it went away. We'll see. Anyway, there's no way a device like that with a limit on number of uses a month would suffice for me. I get way to many CH.
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