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ATI Neurostimulator System CH2 Trial (Read 11513 times)
wimsey1
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ATI Neurostimulator System CH2 Trial
Sep 23rd, 2015 at 9:30am
 
Hello everyone. It's been some time since I last posted. I sort of dropped off because nothing was working for me and I really had nothing to say. The D3 regimen did not help and I drove my levels to 100. ONB's, blind and guided (3 this year) did nothing. I didn't feel I had anything more to contribute except to say I am still here, chronic, intractable and looking for a way to get past these things.

Well, I am still here. Still chronic. Still intractable. Managing with O2, imitrex and Migranal. I have 4-6 attacks a day and a good day is a day with O2 only and not needing chemical interventions.

Three or four years ago DJ posted about the ATI Neurostimulator trials and I responded that chronics like me could have some hope if they worked. The success has been pretty impressive and they are now in the second phase, and I am enrolled. That's what I wanted to tell you.

The trial is a 3 year trial. A neurostimulator about the size of a quarter, or an almond, is surgically implanted through the gum onto the maxillary arch. When it is activated through the use of a handheld device it stimulates the sphenopalatine ganglion nerve using a variable stimulus to interfere with the the cluster. Trial participants are saying it "turns the cluster attack off."

It is a double blind study so I won't know what unit I will receive until I try using it. In this study everyone receives an active handheld remote after 7 months is encouraged to use it for the remainder of the study, about two years. If it is effective we get to keep the system and keep on using it.

Trials in Germany are reporting an 86% success rate. That is huge for chronics and intractables like me. If all ya'll are interested I will keep posting. If you're in the New England area, there are still open trials available for chronic and episodic sufferers.

Thanks for listening. God bless. lance
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LasVegas
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Re: ATI Neurostimulator System CH2 Trial
Reply #1 - Sep 23rd, 2015 at 1:04pm
 
Hi Lance,
It's been a while since I posted also. Good to see your photo and read your words  Wink

Sorry to read you are still chronic, despite all your diligent efforts. Good to read you are enrolled in this trial. the 1st thing to my mind when you were describing it was from a Marlon Brando movie filmed in 1996 called The Island of Dr. Moreau. If you haven't seen it, Netflix! if you have seen it, you understand my thought.

The way you describe the trial, it sounds very hopeful, especially with a 86% success rate.  Wishing you all the best pal  Wink Keep us posted!

-Gregg in Las Vegas
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Mike NZ
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Re: ATI Neurostimulator System CH2 Trial
Reply #2 - Sep 23rd, 2015 at 6:50pm
 
Good to see you both back.

Hope the trail goes well Lance, with you getting the effective hand unit and that you're in the 86% set of people. Whilst D3, imitrex, oxygen and similar work well for many, we really need more options like this that work for those who can't / don't benefit from everything else.

Any idea if it also works for migraines?
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wimsey1
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Re: ATI Neurostimulator System CH2 Trial
Reply #3 - Sep 24th, 2015 at 7:06am
 
Thanks for the welcome Gregg and Mike. I'm pretty sure this unit started with migraine sufferers but not certain of that. My front line is still O2 but the frequency and intensity of the CHs is making it impossible for me to get through more than a half day of work. So...I'm jumping at this. At worst I'm bionic. Who knows what super powers it might give me? But I'll settle for taming the beast. I get the implant at the end of October. God bless. lance
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ddespainsd
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Re: ATI Neurostimulator System CH2 Trial
Reply #4 - Sep 28th, 2015 at 5:29pm
 
I'm also participating in this same trial in Southern California.  I have the CAT scan this Friday and will speak with the surgeon the same day.  I have been chronic for 16 years with only a few breaks during this period.  I also use oxygen at 25 lpm as a first line of defense.  However, this is sometimes hard to cart around everywhere I go and very inconvenient or impossible for any travel that involves a plane flight. 

I still have a few questions about the study or others that have participated already. Do you know if the cluster really ramp up during the three months before the stimulator is activated?

Thanks,
David
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Mike NZ
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Re: ATI Neurostimulator System CH2 Trial
Reply #5 - Sep 29th, 2015 at 4:30am
 
Hi David and welcome

Do you have imitrex injections or nasal spray for when out and about where you can't have your oxygen?
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clustermike62
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Re: ATI Neurostimulator System CH2 Trial
Reply #6 - Sep 29th, 2015 at 7:35am
 
Hi Fellow Cluster sufferers.

I am in Australia and have suffered from cluster headache for fifteen years with the condition progressing from episodic to chronic in the last four years. I have up to three attacks a day and have tried every treatment in the book. All the various triptans, steroids, oxygen, verapamil, lithium, ergots - the list is simply too long to quote. In desperation I would try anything.

In any event someone suggested I try a small non invasive micro stimulator. This one is made in the U.S and has two pads and transmitter. I looked at this small device and thought this could not possibly make a difference. It is used for general aches and pains.

Well what a major, major difference. It blocks a very significant amount of the pain and even though you have the attacks you simply do not feel that agonizing and diabolical pain. You may be a little uncomfortable but it can be controlled with Panadol.

I have now been wearing the device for 2 weeks and it has given me major encouragement. I am disinclined to think I am experencing some kind of plecebo effect because I have been able to sleep without those demon night attacks.

I am going to make contact with the guy at the top before he has surgery because I was on the list too. I'm not saying it is for everyone or it is a panacea but it may help some of us. It states on the box not to use it if you have a pacemaker and not to place it on your  head. Frankly, if it is between putting the stimulator on my head or putting a bullet through it I know which one I'm going to choose -every time.

Any questions please let me know.

Be strong folks.

Regards

Mike
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ddespainsd
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Re: ATI Neurostimulator System CH2 Trial
Reply #7 - Sep 29th, 2015 at 10:46am
 
Hi Mike NZ,

Yes, I have Imitrex injections, but only receive 8 shots every 22 days since this is what the insurance will pay for right now.  I also use 80mg Verapamil/4x day for prevention.  The number of injections are inadequate when the headaches really ramp up.  Also, I will start getting rebound headaches if I use too many.  I'm very hopeful that the stimulator will provide me with another alternative to the norm.

David
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Mike NZ
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Re: ATI Neurostimulator System CH2 Trial
Reply #8 - Sep 30th, 2015 at 12:27am
 
ddespainsd wrote on Sep 29th, 2015 at 10:46am:
Yes, I have Imitrex injections, but only receive 8 shots every 22 days since this is what the insurance will pay for right now.  I also use 80mg Verapamil/4x day for prevention.  The number of injections are inadequate when the headaches really ramp up.  Also, I will start getting rebound headaches if I use too many.  I'm very hopeful that the stimulator will provide me with another alternative to the norm.


If you only get 8 shots, you might be able to split them as for most people half the standard dose will abort a CH. Find more about this - Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to Login or Register.

Another option is to get you imitrex in a vial and inject yourself with what you need to abort a CH. This can make the limited imitrex you get go further.

With using a lower dose of imitrex it is possible that this might reduce the chance of getting rebounds.

What a lot of people do is to still get their imitrex when out of cycle, so they have a stockpile for when their cycle comes around.

With verapamil, 320mg a day is in the typical range of 240-360mg a day that most people find effective, but there is the potential to go higher, but work with your doctor around any dose changes.

Hopefully the stimulator will be another option for you when CH strikes.
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wimsey1
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Re: ATI Neurostimulator System CH2 Trial
Reply #9 - Oct 8th, 2015 at 7:39am
 
I appreciate all of the replies and the interest. I hate the idea of the surgery and implant, but love the possibility that a nonchemical intervention might work. The study has shown great results, so....Anyway, I go for the presurgery screening this Monday. As for the use of Imitrex, I understand the concern. I use .25m (half vial) and stretch out the Rx that way. I also have Migranal which I use occasionally. And I do stockpile. It's a crazy life but it is what I have. I have learned to maximize the time between attacks, sometimes short, sometimes longer. It's better than just sitting around waiting for the pain. God bless. lance
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Re: ATI Neurostimulator System CH2 Trial
Reply #10 - Dec 15th, 2015 at 6:01pm
 
Hi i am new to the boards. i am also signed up to participate in this study has anyone that replied gone through with the procedure? i am interested to find someone who has had the implant done to see what he recover period is like. I was first diagnosed with CH in 1985 and have tried almost every conventional treatment. Hate the idea of the surgery but would love to stop taking all the drugs
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LasVegas
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Re: ATI Neurostimulator System CH2 Trial
Reply #11 - Dec 25th, 2015 at 7:45pm
 
3 G's, huh? Your 1st post seems advanced. You are obviously no rookie suffering since 1985. Please tell us about yourself...

Where are you from for starters?
What prescribed meds are you currently taking?
Are you episodic or chronic?

-Gregg in Las Vegas
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Re: ATI Neurostimulator System CH2 Trial
Reply #12 - Jan 1st, 2016 at 3:29pm
 
Lance, curious to see how you are doing. Did you get the implant? Any help?

Hope all is well!
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Re: ATI Neurostimulator System CH2 Trial
Reply #13 - Feb 15th, 2016 at 7:25pm
 
Google for Pulsante for the device.  Basically it's the size of an almond and there's a small wire that's near the SPG.  You hold a transmitter up to it and it sends out signals to quiet it down.


My doc at Stanford, Robert Cowan,MD  is involved in the study and wants to enroll me.  He said it hasn't started yet - (although this might be a different study but the same device).  He said the study is going to happen sometime this year.  Placebo patients get the real implant but their transmitters are non-functional.  He said the results from Europe are very promising.  After the 60 day trail the placebo patients are given a real transmitter.

I had a failed RFA last year - they couldn't find the nerve.  But while they were in there they injected a bunch of steroids around the sphenopalatine ganglion.  This gave me major relief for a few months.  So anything in that area seems promising.
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Gregg
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Re: ATI Neurostimulator System CH2 Trial
Reply #14 - Feb 21st, 2016 at 10:57am
 
LasVegas wrote on Dec 25th, 2015 at 7:45pm:
3 G's, huh? Your 1st post seems advanced. You are obviously no rookie suffering since 1985. Please tell us about yourself...

Where are you from for starters?
What prescribed meds are you currently taking?
Are you episodic or chronic?

-Gregg in Las Vegas

Sorry for the late post have not checked site in a while
I am from Pa currently take 500 verapamil daily. Have been chronic for 12 years. Before that  treated the episodes with Sansert and imetrex-oxegen as needed.
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Giovanni
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Re: ATI Neurostimulator System CH2 Trial
Reply #15 - Feb 27th, 2016 at 11:48am
 
Right now they are gathering potential candidates in the Raleigh/Durham area for this study. I called and the program nurse will be calling me on Monday, February 29th for a telephone interview. I don't know if I'll qualify for the study. This cycles started in mid June 2015; before that a nice remission; before that a 2 year cycle.
John
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Re: ATI Neurostimulator System CH2 Trial
Reply #16 - Mar 14th, 2016 at 3:44pm
 
I live in Southern California. I heard there is a study beginning at USC. I called the phone number listed and they told me that they will contact me when everything is in place.  I'm a 34 year episodic/chronic demon beater and would love to be close to normal again. If and when I hear anything from USC, I will respond here.
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Peter510
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Re: ATI Neurostimulator System CH2 Trial
Reply #17 - Mar 14th, 2016 at 4:27pm
 
Michael,

I would urge you to try every other alternative before getting anything implanted in your body. Testing for implanted neurostimulators has been going on for years. Indeed, I was offered the treatment back in 2012.

I researched it and thought..." OK, but only as a last resort".

Since then I am still chronic, but managing well enough on D3. Still get hit at least every day, but Kip 2/3 's mostly (except when I get an infection and then it's back to the bad old days for a short while). I'M on no MEDS and O2 will kill it off quickly.

I have put the idea of implants very much to the back of the queue. There is a non-invasive unit that does the same thing by putting a hand held unit to your beck and stimulating the nerves in the same way.

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Best wishes,

Peter.
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« Last Edit: Mar 14th, 2016 at 4:34pm by Peter510 »  

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Michael63
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Re: ATI Neurostimulator System CH2 Trial
Reply #18 - Mar 14th, 2016 at 6:15pm
 
Peter,
Thanks for your input.  I too am not overly excited about the implants. It would have to be something very radical in my current regimen.  As of today and 3 days into the D3 therapy, I feel that this type of treatment suits me better. I don't like any of the drugs I have tried over the years because of ineffectiveness or side effects, so I am excited to get on board with D3.

Over the next few weeks, I hope to report good news about D3. It is really cost effective and simple to follow.
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lancashire Lad
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Re: ATI Neurostimulator System CH2 Trial
Reply #19 - Mar 14th, 2016 at 6:38pm
 
Re neurostimulation; I would bow to Batch's better knowledge (on this occasion) in ECM (Electronic CounterMeasures) but sadly he couldn't talk about the ins and outs.

The basis of the technology is you stop an electronic system working (doing what it's intended to do) by what ever means you have at your disposal (and if you don't have something at your disposal you find one).

My view is, it is likely that CH is the manifestation of a malfunctioning chemo/electronic system in the brain (and before anybody says No Shit Sherlock, there are other theories), the CH response could be a very early mechanism in mammals to shut the body down because of a threat.

But lets assume its a rogue nerve not doing what it should (perhaps because something is pressing on it and stuff doesn't compute).

Ways to take down an intended /unintended signal is to block it, confuse it, distract the sensor, create a decoy signal (to occupy the processor) or get the signal to do something the originator did not intend (and there we get into off limit territory).

I have no doubt that this technology can have an impact on CH but what the down side is must be treated with caution. I think it must be treated as an option some way down the road.
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Re: ATI Neurostimulator System CH2 Trial
Reply #20 - Mar 14th, 2016 at 7:45pm
 
I just wanted to say congratulations to all of you in the study. I hope you get the real deal but in any case you'll eventually have the implant and the hope of a headache free life.
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Re: ATI Neurostimulator System CH2 Trial
Reply #21 - Mar 14th, 2016 at 8:32pm
 
maryo

Good point you make about the placebo candidates but the strange thing about the head/mind/brain subconscious (whatever causes the effect) in pain studies placebos “work” 30% of the time.

This is not an effect that the conscious mind can “normally” recreate. External sources can eg hypnotism, meditation (where some spiritual/natural force(s) can be invoked), prayer or trauma. etc etc.

Which tells us (if it our head doing it – and not a conglomeration of the brain, gut, organs, etc etc) our head is happy to attack us.

We know our bodies can turn on us with various fatal illnesses, we know our “mind”  can put us in a crippling state of depression and/or anxiety but why would “nature” have allowed that? Why was it not lost along the evolutionary path?

What ever the mind is, it is a key figure in CH, not one we can normally harness and control but external influences can.
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Re: ATI Neurostimulator System CH2 Trial
Reply #22 - Mar 15th, 2016 at 7:31pm
 
I read recently a comment on one study that said placebo's in the case of CH is almost unethical .
To sentence a subject to extreme pain so you can get a comparison is unethical IMO .
This is my first post here , but I am not new to the circles.
I am chronic , I had some success with Verapamil but I am falling back into the cycle of pain .
I am just so sick of it all .
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Peter510
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Re: ATI Neurostimulator System CH2 Trial
Reply #23 - Mar 16th, 2016 at 4:53am
 
Hi MG......B,

Welcome to Ch.com. You've found the right place. There is a wealth of knowledge here and everyone knows just what you're going through.

In order for us to offer suggestions or advice it would be helpful if you filled us in a little on your history.

How long have you been living with CH, are you episodic or chronic, Where do you hail from, are you working with a headache specialist, what MEDS have you tried, both preventative and abortive.

We do understand and there is always someone here .

Best,

Peter.
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Re: ATI Neurostimulator System CH2 Trial
Reply #24 - Mar 31st, 2016 at 12:37pm
 
This trial started quite awhile ago. Has anyone here actually had the implant?
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