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 Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or

For additional informaiton, you can contact Amy Pruitt at Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to or

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

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!).

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

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

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

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 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!