Official Title: Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache

The Carolina Headache Institute (Chapel Hill, NC) will be one of the centers participating in a nationwide study conducting a multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache.

If you are interested in participating or for more information, please see START PRINTPAGEMultimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or END PRINTPAGE

For additional informaiton, you can contact Amy Pruitt at pruitta@carolinaheadacheinstitute.com

For a complete list of participating sites, please see the clinicaltrials.gov website.

Any body going to give this a try.  I would if I was close enough.  Be curious what the theory is and in anything new that might work.

Thanks for posting this.

I was looking into this - but hopefully I am out of cycle, and from what I read you need to be in cycle and the study starts in Feb - my first cycle started last may, not sure when my next will be - with the d3 regiment maybe never (I HOPE!).

The Company sponsering this study gave a presentation at the CB Conference in Chicago in Sept. '13. The study began in Feb. 2013 and ends in June 2014.

I'm close to one of the study sites and intend to volunteer @ MHNI, Ann Arbor, Mich. I'm in heavy cycle and willing to try this, it has shown at least some success.

Don

My first appt. for the study is 10/29/13. I'll update with any future info and results.

Any one interested in being part of this, there are multiple study sites around the USA. You can find them on the link DJ provided.

Don

Hope it works.  Appreciate any info you provide in the future.

Came home with the GammaCore unit today. It seemed to stop a mild hit but a little early to say possitive results. For the first week I may or may not have a real device.

Nov. 5, I will receive the assured real thing. They are paying me to do this study. $100 first return, $75 for the second.

Don

Thanks DJ for posting this information.

   I failed to meet the criteria for the study because "I've already had a stimulator" (that failed) almost 10 years ago which still precludes me from any stim trial participation.

What I'm told is that this 'device' is not implanted at all (at least not during any 'trial' phase) and it consist of what may or may not be an electrical stimulator that you hold in a certain area (where electrical stimulation is wanted by the clinicians). The 'device' is to be held in this spot for 90 seconds and repeated at regular intervals unless otherwise instructed by your doctor in control of your trial phase. Does this sound correct (for those that may currently be in this trial)?

Even though a person in this 'trial' may or may not be in a control group to begin with, each patient WILL have access at one point or another to a 'real device' which they hope has potential for some success.

Personally, IN MY OPINION, I DO NOT see how any device like this is going to work. An external stim ? What are we talking here ? A 'T.E.N.S. Unit' or BLUETOOTH or what ? LOL! Sorry about my skepticism and I surely hope to be proven wrong by clusterheads getting relief.... but right now this is sounding a bit like a magnetic bracelet to cure Meegraynes & arthritis  !

Good Luck & I hope it works for someone. I'll be watching for results.

I4B

I'm waiting to hear back from MHNI myself to see if they can get me into this trial. There are 2 questions in concern as far as them allowing me to try it.

#1: Was trying an ONS TRIAL (Not fully implanted) for 6 or 7 days considered as a 'previous surgery for cluster headache' ?

#2: Do they consider myself as healthy enough t try the stimulator? They want 'healthy' clusterheads for the clinical trials.

TRUE STORY --> John Doe had chronic clusterheadaches for 10+ years. They allowed John to participate in a clinical trial for an electrical stimulator. It was helping John ALOT and making a HUGE change for him, improving his life. But before the trial ended, John had an abdominal aneurism. All the doctors involved agreed that the stimulator had NOTHING to do with John's aneurism BUT since John had this happen while participating in his trial, they MUST report this as an Adverse Event in the trial's results that makes them look bad. They don't like that! They want to report GOOD RESULTS because they want to $ell their stimulator more than they want to help John, even if John is the worst case of clusters out there. It's about the $$ for them, NOT as much about helping the CH patient.

Yes, that IRKS me !!

I4B

DON: Please keep me or this thread updated (I will follow it) as I'm hoping you get great results and I'm also hoping that I get to try this at least ... especially since 'm losing my other weapons in this fight against the BEAST ! THANKS AND GOOD LUCK DON !!  (I just thought ...Don could make $100 for EVERY VISIT or else DON could stub his toe resulting in the LISTING OF ADVERSE EVENTS DURING CLINICAL TRIALS that 1 patient got clumsy, loss of balance, and / or pain in toe or toes, etc.   ...LOL ! You get the idea, i'm sure!) (J/K!)

I4B

I had to treat 5 attacks with the possible "sham device". I was given a real one a week ago. I can detect a difference in this device. So far I've treated 3 attacks with the real device.
My results have been limited. It seems to work for only minutes.

The protocols for the study are not CH friendly. No abortive meds including O2 for 2 hrs prior to using the GammaCore and for 15 minutes after. We all know a CH hit can be out of control by then.

I4B, what you wrote is correct but you use the device for 90 sec's 3 times in a row. I think you have a good chance of being accepted as they had to clear me because I have PAD, artery desease.

They're having a hard time getting CH patients due to the protocols. I am still hopeful that in someway I'm helping our ClusterHead family.

Don

Thank you for trying this, especially as it isn't exactly CH friendly on the protocol. We all know what a CH is like when you can't abort it like you normally can with oxygen or similar as soon as possible.

I am getting the device tomorrow and will participate in the study. Once the "study" part is over, I was told I will get a real device (even if I get a sham device initially). Looking forward to the results. I am chronic and could use some help. I'll keep you updated as to the results.

I was told I CANNOT try the VNS device due to 'prior cluster surgery'. I had a ONS TRIAL 10 years ago where NO DEVICE was implanted but a small incision was made and wires were placed then taped to my back and down to a battery/control device also taped to me. Six days of a useless pain in my neck while still having cluster attacks stops me from trying this. Thanks GammaCore for your help!  >:(