Disclaimer:

Please note that I am not a doctor or a scientist, and cannot provide medical guidance or advice.

Further, I cannot provide guidance on nutritional or alternative treatments. Anything shared by me is not to

be taken as guidance or advice for other’s treatment needs. I encourage patients and the public to use the resources

I share to further their own research as well as speak to their doctors. While I will post on my social media when

clinical trials are happening and results thereof, I am not in control of trials, I do not have an ‘in’ to help patients get into trials,

and cannot speak to anything regarding trial protocols. My mission is to share my story in order to further

expand resources for research of bioelectronic medicine and advance access.

Please feel free to share your story with me at kowens4@northwell.edu and I'd be happy to add you to the Feinstein Institute's

patient database to be notified in the event of a clinical trial that fits your indication

and needs becomes available at the Feinstein Institutes.

 

I encourage you to visit clinicaltrials.gov regularly to learn about clinical trials that may be happening

at other medical centers around the world and contact those facilities if you find one that fits. 

 

SO, WHAT DOES THE VAGUS NERVE DO?

Dr. Tracey says that the Vagus nerve is like the “transatlantic undersea cable” of the body,

carrying tens of thousands of individual wires to all the organs of the body.

The wires (nerves) control the activity of cells in each organ. When the vagus nerve is electrically stimulated,

it causes an electrical reaction that soon becomes a chemical reaction in the spleen,

which then turns the production of excess inflammation off.

Click the link below to view Dr. Tracey’s Ted Talk:

https://www.youtube.com/watch?v=AJH9KsMKi5M

 

WHO RAN THE TRIAL YOU PARTICIPATED IN?

SetPoint Medical: Click here to learn more about their pioneering work in conducting clinical trials

and find out about the current trial available for patients with rheumatoid arthritis.

 

WHO DID THE RESEARCH?

Dr. Kevin Tracey and his team at the Feinstein Institutes for Medical Research in Manhasset, NY. 

 

ARE THERE ANY SIDE EFFECTS?

There have not been any reported side effects in clinical trials.

 

WHAT IS YOUR EXACT DIAGNOSIS?

Crohn’s disease with seronegative enteropathic arthritis,

extraintestinal manifestations of pyoderma gangrenosum, and osteoporosis.

 

WHAT MEDICATIONS HAVE YOU TRIED?

I was on and off of prednisone ever since diagnosis — generally at 40 to 60 milligrams during really bad points,

and then at 10 or below for maintenance. That was really the only thing that held me over.

Until vagus nerve stimulation, I was never in remission. I tried every biologic and DMARD under the sun:

 Remicade, Humira, Cimzia, Entyvio, Enbrel, Methotrexate, Stelara, Simponi, Imuran, 6mp,

Pentasa, Entocort, Uceris, Sulfasalazine, Asacol, Plaquenil, Celebrex, and Lialda.

None of them worked. My body always built up antibodies against everything.

 

WHAT MEDICATIONS ARE YOU ON NOW?

None. 

ARE YOU HBLA-27 POSITIVE?

No.

 

IS IT TOO LATE TO JOIN THE TRIAL YOU WERE IN?

Yes, but I encourage you to check in with clinicaltrials.gov every week and type “Vagus Nerve Stimulation”

into the search bar to see if there are other trials happening around the world.

Further, you can email me at kowens4@northwell.edu and I will add you to our patient database

so that when the Feinstein Institute conducts a clinical trial that fits your needs, I will contact you immediately. 

 

IS IT APPROVED BY THE FDA YET?

It is only approved for epilepsy and depression at this time.

SetPoint Medical has obtained Breakthrough Device Designation from the FDA,

which means trials so far have proven to be more effective than current therapies

available to patients today. Because of this, at the conclusion of the current phase three trial,

if it continues to prove safe and effective, it will be fast-tracked to

gain FDA approval for rheumatoid arthritis. 

 

WHAT IS TRANSCUTANEOUS VAGUS NERVE STIMULATION? 

It is a way to stimulate the vagus nerve externally, so it does not require an implanted device.

Our research and trials at the Feinstein Institutes have been successful in rheumatoid arthritis and lupus,

and researchers will continue to explore more indications.       

 

WHAT CONDITIONS HAVE THE POTENTIAL TO BE TREATED BY VNS?

The possibilities for treating specific diseases are endless:

Feinstein’s researchers are exploring the role of the vagus nerve in sepsis, diabetes,

arthritis, Crohn’s, lupus, and obesity, and there is something called the ‘neural tourniquet’

that is in trials for treating hemorrhaging for soldiers wounded in war and post-partum mothers.

 

What’s more, this year Dr. Sangeeta Chavan and her team discovered a small cluster of neurons within the brain stem

that is responsible for the production of inflammation in the immune system,

traveling by way of the vagus nerve. 

Further, the field of bioelectronic medicine has led to the discovery that paralysis need not be a permanent problem,

but instead, something treatable by stimulating nerves. At Feinstein, led by Chad Bouton,

our researchers are doing just that by developing a product called ‘the sleeve’ that paralyzed patients can

wear over their arm to cause movement, allowing them to utilize both their fine and gross motor skills

to have the independence they so desire. 

We have established both public and private partnerships with both industry and government entities

such as GE, Unit Therapeutics, GSK, DARPA, and more, who are working with us to advance the research of

using neural pathways and neurotransmitters to control and treat diseases, as well as develop more therapies

and devices such as ultrasound therapy and more to modulate the immune system without the use of drugs. 
 

 

HOW DID YOU AFFORD TO PARTAKE IN A CLINICAL TRIAL IN AMSTERDAM?

We sold everything that wasn’t nailed to the floor and our community came together and fundraised to make it possible.

 

ALSO — WHO IS MURPH?

Murph is my vagus nerve implant, inspired by the movie Interstellar. The main character, Coop, describes how Murphy’s Law isn’t what it’s thought to be — it has been misconstrued to mean that “anything that can go wrong, will,”

but he says that what it really means is:

“Anything that can happen, will happen.”

That seemed to fit.