Multiple Sclerosis Pilot Study Evaluating PoNS Yields Promising Results
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Helius Medical Technologies, Inc., a company dedicated to neurological wellness, recently announced that the multiple sclerosis (MS) pilot study assessing the company’s investigational Portable Neuromodulation Stimulator (PoNS™) device has met all of the study’s goals.
PoNS is a non-invasive device that allows the delivery of neurostimulation through the tongue. The device is based on the concept that the tongue can be used as a natural, direct entry to stimulate the brain, especially since it is richly innervated by thousands of nerve fibers and interconnected by two major cranial nerves to the brainstem.
The PoNS system is currently being evaluated in Canada, at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center, as a therapy for gait and balance disorder in patients with MS. In total, 14 participants (7 with active MS and 7 control individuals) were submitted to this non-invasive brain stimulation technology along with physiotherapy. The potential clinical benefits of PoNS neurostimulation were evaluated and functional magnetic resonance imaging (fMRI) was employed to determine the device’s effect while participants performed working memory and mental imagery tasks, with or without stimulation.
fMRI results revealed that the PoNS device seems to facilitate neural plasticity. In fact, after treatment, patients with active MS exhibited a brain function similar to healthy individuals. MS patients also experienced a significant improvement in balance after 14 weeks of treatment. Furthermore, researchers reported a good safety profile for PoNS therapy.
“The researchers from the Montreal Neurological Institute and Hospital are pleased with the execution of this study and are excited by the results as they point to a new frontier in research in brain injury rehabilitation. We are happy to be on the forefront of research that may bring this technology to patients in need,” said the study’s Principal Investigator, Dr. Gabriel Leonard, in a press release.
“We are delighted with the findings that are consistent with prior studies. The fMRI data show that the PoNS may be changing the way the brain functions,” added Helius’ Chief Medical Officer, Dr. Jonathan Sackier. “Measuring brain activity and the changes taking place through fMRI is designed to determine in an objective way if, in fact, there are indications of neuroplastic change in the brain.”
This pilot study also allowed the research team to identify factors that need to be improved in the design of future trials, including recruitment, screening, randomization and execution. The authors determined that a sample size of 128 participants (64 with active MS and 64 controls) would be appropriate for a definitive MS clinical trial study.
“This is an exciting and promising development for our company, patients and the healthcare community. Addressing symptoms caused by MS has been a challenge for the medical community and we are excited to pursue PoNS as a potential therapeutic tool,” said Helius’ CEO, Philippe Deschamps. “We reached all the objectives of this study and are optimistic as we continue to advance the PoNS device through clinical trials.”
The results of the study will be submitted for publication in the near future.
In the United States, the PoNS device is currently being tested for the treatment of balance disorder in patients with mild to moderate traumatic brain injury. Helius plans to file the device for U.S. Food and Drug Administration clearance.
Donald
Will I be able to get this through the VA? I have RRMS and my gait and balance are bad.
Era
Hello Donald,
I have been researching the PoNS device and have spoken to Luke Norman, from Helius, here in Vancouver about the possible release date.
Have you found a possible way to purchase this device privately?
I am sure you have seen this:
https://www.youtube.com/watch?v=EmElrCIWKDU
cheers,
Era
Roberta Brooks
Yeah, well Montel being who he is can drop everything and fly to Wisconsin to get treatment. ...What about the rest of us? ???
Patricia Milliken
Is this similar to what Montel Williams participated in at the University of Madison Wisconsin several years ago? As I remember it involved placing something on his tongue that stimulated his brain.
Shirley
It certainly is Patricia. That was a few years ago. Now how come nothing ever came of this? I know Montel would be shouting from the rooftops if it worked. Obviously another scam to justify their waste of more money for nothing but, fattening their wallets.
Sharon klug
I also can't walk and my balance is off!
Any recommendations would be great!
Any help would be great, from anyone!!
Tonie
Montel Williams has introduced this product to the military for clinical trial for TBI soldiers (traumatic brain injury) few years back. He has been trying very hard to bring this product out for MS also. I'm not sure how well the TBI trial resulted. I've been following this device for 3.5 years and tried so hard to get my husband on the clinical trial in Wisconsin. Wish I could see some fact data on the trials.
Dave Uherek
When do expect to market and sell to the general public. Do you have to go through another set of trials.? I wouldn't think so since is not a drug. Also, What is the NDA clearance? Any news would be helpful. Thanks.
wayne fenton
When the hell are they going to start giving us these treatments instead of just telling us and then pulling them away from us , theres more people that need them than the special trial subjects who are more than likely in better condition than most who do need them and have no other options. Your drugs don't work what a waste of time and money spent on them.
DAVE
I agree wholeheartedly. It looks like we have 2 enemies here. MS and the FDA. God Bless.
Shirley
They are ALL TALK. NO ACTION. Nothing new for decades besides expensive, ineffective, further debilitating, drugs based on an UNPROVEN autoimmune theory. Yet people blindly give money to these organizations to further THEIR quality of THEIR lives. Certainly not ours. Prove me wrong. Please.
Marge Wales
Will the pons be effective for someone who has PPMS? When will it be available in Canada and in what cities? Sounds promising but who will it really help?
jo
Pharmageddon Enough of the Big Pharma BS... It is good people are waking up now we all need to speak up tell the Docs we need to get wellness treatments that work no more toxic synthetic drugs...
Saudi Arabia's economy is going off oil by 2020 time for big pharma to do the right thing and get past money start healing people
Thank you
Era
I completely agree with you. I believe there IS a pharmacy conspiracy! Currently people are prescribed medication to keep us at "bay" but we would rather have a prescription for a medication that would make us BETTER!
David
It is ok to drag your feet on this. Most of us do already. Again, all replies and no answers. Or results. Thanks. Do not not need to walk anyway. Godspeed! David
Micky Revithis
my husband has MS he was given a drawer full of pills resulting to nothing !! he was in pain etc.. until We found this young man's story
its worth watching
all I can say its been 8 months my husband only takes vitamins !!!!!!! and a sleeping pill
he has no pain
worth checking
http://www.mshope.com/
hope this thing under your tongue works also that will be the best with the diet and vitamins !!!!!!!
Djon Bland
When and where can i buy one?
jo
It seems it is simply a glorified tens unit that cost under $30 but the FDA suppresses because it will reduce drug sales.. so sad... if we could ever get past money we would THRIVE as a human race.
Kittydog
It's currently in phase 3 clinical trials for FDA approval. It takes years of trials to get FDA approval for drugs and medical devices.
http://tacklingtbi.com/
cynthia
the last comment was a year ago......any update on whether this works ?
Martin
Great question and I would love to know myself.
As long as we are a little sick it’s still little sick – as far as whoever they are are concerned – then the money will continue to flow in.
Thanks
Felipe
Hi Any idea when this device will be avaliable in Brasil ?
Dave Uherek
Back in 2015- this device was stated to be helpful for various problems caused by MS. So why has there been no progress over the past 5 years. Montel Williams was lucky enough to experience the benefits of the PONs before most people could not use. People had to resort to drugs and pharmaceuticals. Well, a big pharma got their hands on this, made a clinical trial out of the PONs device and now it is locked away in a vault and cannot be used fo MS. Oh but the big pharma companies can now make a few bucks. Here is wishing hope for all of the poor folks with this slow death of a disease scaled MS?. Peace
BW
The TRUTH is the PoNS does NOT Work like they say! I know of 28+ people with TBI, MS, Stroke or Parkinsons that had very little to no improvement and I and some others even got worse and did produce side effects. I had to double my Medications after 5 weeks of use.
It is a very intense protocol 5-6 20min sessions of PT a day + two 20 min warm-up/workouts a day 6 days a week Exhausting, to say the least.
The medical industry does not want to and has not cured anything it would reduce Drug sales, which is criminal really sad! The only thing they have cured is wellness.
I suspect the original PoNS device was different and may have worked on some people but it has now obviously been dumbed down to be much less effective.
Not to mention it is $30,000 Canadian for leasing it for 14 weeks (not owning) Pure GREED! The device should be under $1,000 to buy and they would still make money. The CEO even said it is a "very simple" device. The price breakdown as I understand it is $18,000 for the 14 week rental of PoNS devise and $12,000 for the PT = $30,000 Canadian.