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

Hi Lance,
It's been a while since I posted also. Good to see your photo and read your words  ;)

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  ;) Keep us posted!

-Gregg in Las Vegas

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?

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

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

Hi David and welcome

Do you have imitrex injections or nasal spray for when out and about where you can't have your oxygen?

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         

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

ddespainsd wrote on Sep 29^th, 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 - START PRINTPAGEMultimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or END PRINTPAGE.

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.

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

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

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

Lance, curious to see how you are doing. Did you get the implant? Any help?

Hope all is well!

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.

LasVegas wrote on Dec 25^th, 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.

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

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.

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.

Research   

START PRINTPAGEMultimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or END PRINTPAGE

Best wishes,

Peter.

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.

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.

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.

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.

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 .

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.

This trial started quite awhile ago. Has anyone here actually had the implant?

Peter5150 is giving the best advice when he says to research the subject yourself.
My basic understanding of how the ATI SPG neurostimulator works is much different than what Lancashire lad says. His musings are "wildly speculative" in my humble opinion and must be duly noted as so.
The implant is meant to stimulate the blood vessels in the immediate area surrounding the SPG nerve bundle. The electrical stimulation causes the vessels to release the pressure they are exerting on the SPG in the same way most other abortives do , through vasoconstriction.
If I'm wrong , and someone has a link or a quotation please post it so that there is no misinformation regarding this topic.

Autonomic Technologies, Inc. (ATI), the developer of the ATI Neurostimulation System designed for the treatment of severe headaches, today announced results of their clinical study in cluster headache, The robust, multi-centre, randomized, placebo-controlled clinical study is the largest study performed with a medical device for cluster headache.

The ATI Neurostimulation System includes a novel, miniaturized device that is implanted using oral surgery, leaving no externally visible scars. When the patient feels a cluster attack beginning, they hold a remote controller up to their cheek to begin the neurostimulation therapy.

The study showed that the ATI Neurostimulation System demonstrated clinical effectiveness in treating cluster headache, and provided significant improvement in patient quality of life and headache disability. The results were statistically significant:
• Pain relief at 15 minutes was achieved in 67.1% of treated attacks compared to 7.4% of sham treated attacks (p<0.0001)
• Pain freedom at 15 minutes was achieved in 34.1% of treated attacks compared to 1.5% of sham treated attacks (p<0.0001)
• The average number of cluster attacks per week was reduced by 31% (p=0.005), and 43% of patients experienced an average reduction of 88% in the number of attacks suffered
• 64% of patients experienced clinically significant improvement in headache disability (HIT-6)
• 75% of patients experienced clinically significant improvements in quality of life (SF-36v2 physical and/or mental component scores)
• Acute rescue medications were used in only 31.0% of treated attacks compared to 77.4% of sham treated attacks (p<0.0001), a reduction of 60%
• The ATI Neurostimulation System was well tolerated, and side effects were comparable to other similar surgical procedures and tended to be transient

Cluster headache is one of the most painful types of headache. Patients may experience multiple attacks daily or almost daily, associated with excruciating pain typically in the area of one eye. Each attack can last between 15 minutes and three hours.1 Often called 'suicide headaches' because of their severity, it is estimated that over 600,000 people across Europe suffer from cluster headaches.

"Cluster headaches cause so much disability that patients are often unable to function normally," said Prof. Dr. Jean Schoenen, Full Professor of Functional Neuroanatomy and coordinator of the Headache Research Unit at University of Liege in Liege, Belgium. "Current preventive treatments are often ineffective, and in many patients acute and preventive treatments may not be tolerated or are contraindicated. This new and innovative therapy offers a way for a significant number of patients to control the debilitating pain of cluster headache."

The ATI Neurostimulation System is a novel, rechargeable system, with an implantable neurostimulator that is smaller than an almond. Designed for the treatment of severe headache, the neurostimulator is activated using an external remote controller (similar in size to a smart phone), allowing patients to deliver as-needed stimulation to relieve the attack. After a headache is treated, the remote controller is simply moved away from the cheek, turning off stimulation therapy.

"The ATI Neurostimulation System is well tolerated and can be used as often as needed, without daily limitations or stimulation-induced side effects", said Prof. Dr. Rigmor Hoejland Jensen, Director of the Danish Headache Center at Glostrup Hospital in Denmark. "Based on the results of the study, this new treatment option offers a significant improvement in quality of life to the majority of patients."

The ATI Neurostimulation System works by stimulating the sphenopalatine ganglion (SPG), a nerve bundle deep in the face that for years has been shown to play an important role in cluster headache.

"For years clinicians have targeted the SPG to relieve severe headache, primarily by applying anesthetics and other agents to achieve a nerve block," said Prof. Dr. Arne May, Neuroscientist at the University Hospital Hamburg-Eppendorf and First Vice President of the German Migraine and Headache Society. "This study provides clear evidence that SPG stimulation is a feasible and effective therapy for the treatment of cluster headache."

"We are very pleased with the positive results of the clinical study," said Ben Pless, President and Chief Executive Officer of Autonomic Technologies. "We are delighted to start making the ATI Neurostimulation System available to cluster headache patients in Europe so that they may control their painful attacks."
The ATI Neurostimulation System is CE marked for the treatment of cluster headache. Initial centres in Germany and Denmark are now treating suitable cluster headache patients with the ATI Neurostimulation System. ATI plans to begin an investigational study of the device in the US in the near future. Patients who wish to explore this new therapy should ask their doctor for a referral to a headache specialist or neurologist who is qualified to evaluate, diagnose and properly manage cluster headache.


Doctors test device designed to 'turn off' cluster headaches
Published on August 19, 2014

For those suffering excruciating pain from cluster headaches, relief may soon be available from an investigational device being studied in a national multicenter clinical trial. Recently, doctors at The Ohio State University Wexner Medical Center performed the first surgery in the United States to insert a neurostimulator to provide relief from cluster headaches, which are more painful than migraines. "Cluster headache is one of the most severe and disabling chronic pain conditions known to humankind. That's why it's important to look at options to help these patients," said Dr. Ali Rezai, director of the Neuroscience program at Ohio State's Wexner Medical Center and one of the scientific developers of this technology.

During the outpatient surgery, sinus surgeon Dr. Bradley Otto and oral surgeon Dr. Peter Larsen inserted the device through a small incision in the patient's gum into the side of the face affected by cluster headaches. Autonomic Technologies Inc. developed the miniaturized, multi-channel peripheral nerve stimulator, which is smaller than an almond, to stimulate the sphenopalatine ganglion (SPG). The SPG is a nerve bundle located behind the nose and is known to play a major role in severe headaches.

"Through an incision about 2 centimeters long, we're able to place this device, then pass it around the back of the maxillary sinus, or the cheek sinus, into this area where this ganglion is situated," said Larsen, who is professor of oral and maxillofacial surgery in the College of Dentistry at Ohio State. "The device is very small, and the patient doesn't even sense that it's there."

When patients begin to feel a cluster headache starting, they hold the rechargeable handheld remote controller to their cheek to activate the stimulator to block the pain signals. The patient's physician can program the device to give the appropriate length and strength of stimulation.

"This nerve control center sits behind the cheek sinus and is involved in the transmission pathway of cluster headache," said Otto, who is director of rhinology in the Department of Otolaryngology at Ohio State. "And so by blocking or short-circuiting that involvement, we think it will help treat cluster headache. The beauty of the device is that there are no internal batteries or other structures that need to be routinely removed. So, once we make the incision in the mouth and we place this device back behind the cheek sinus, it can be left forever."

It's estimated that nearly 400,000 people in the United States suffer from cluster headache, which can happen many times each day, with each one lasting from 15 minutes to three hours. Cluster headache is often called "suicide headache" because the pain is so intense. Cluster headaches typically involve one side of the head, and are much more common in men. The headaches are so severe that they cause very disabling sharp and stabbing pain around and in the affected eye, along with pain in the nose, head and temple. Drooping eyelids, redness and tearing often accompany the eye pain, and there is no cure. "SPG interventions have been around for the past 100 years," said Rezai, including using anesthetics to block the SPG to surgical procedures to cut the SPG or chemically burning it. "The main advantage of neurostimulation is that it's reversible and adjustable, and you're just modulating and blocking the pain signals."

In all, up to 120 patients with cluster headaches will receive the experimental device as part of the multi-center clinical trial that will last several years.

Source:
The Ohio State University Wexner Medical Center

So has ANYONE here actually had the implant?

G'day trsixy, welcome, and I know you've asked this same question before.

I can't answer it myself, and we're usually much better at attending to new queries, but I just wanted to say hello and wish you well.

I have had the ati neurostimulator implant and device for a year now. It has had absolutely NO positive effect on my chronic cluster headaches. Very disappointed with this device. It has never lessened the pain of an attack for me ever.

Hi and welcome Glendale

Sorry that the implant didn't help you at all.

Are you using an effective preventive and do you have abortives?

Working with a headache specialist?

Tell us more and we may be able to help.

I posted a couple times quite awhile back asking if anyone had the implant. I had mine wayyy before that but you agree not to discuss it. MIne was 2 years ago, One of the first. like
Glendale66 zero help.
I did get a permanent nimbness in my cheek and lip though.

I had this implanted back in 2015 and had it removed November of 2017. No help to me at all, if anything it caused more frustration then anything. I also have numbness in the roof of my mouth upper lip and nostril.