PoNS® and PoNS Therapy® Frequently Asked Questions
WHAT IS PoNS?
PoNS (short for Portable Neuromodulation Stimulator) is an innovative, non-surgical medical device that gently stimulates the surface of the tongue, exciting the cranial nerves to promote neuroplasticity.
Neuroplasticity is the ability of the brain to make adaptive changes related to the structure and function of the nervous system.
Used in conjunction with physical therapy (PT), PoNS improves gait in individuals with mild to moderate symptoms of multiple sclerosis (MS) – helping them GET BACK IN STEP WITH LIFE.1-3
Individual results and experiences may vary.
HOW DOES PoNS WORK?
The device consists of a controller and a mouthpiece that contains gold-plated electrodes. The controller goes around the neck. The mouthpiece rests on the front of the tongue with the electrodes facing the tongue.
When the PoNS device is on, the electrodes on the mouthpiece send mild electrical impulses to the tongue (a gentle sensation similar to drinking a sparkling beverage). These impulses stimulate the cranial nerves that have direct connections into the brain through the brain stem.
When combined with physical activity, this stimulation sets off a cascade of activity in the brain, which promotes neuromodulation and, consequently, neauroplasticy to improve gait.1-3
Individual results and experiences may vary.
WHO SHOULD USE PoNS THERAPY?
The PoNS device is indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program for adults aged 22 years of age and over by prescription only.
Are you (or someone you know) living with MS and having trouble with walking? Take the Rate Your Gait walking assessment.
Talk with your doctor about PoNS to determine if PoNS Therapy is right for you. Download the Doctor Discussion Guide to help guide your discussion with your doctor about PoNS Therapy.
HOW EFFECTIVE IS PoNS THERAPY?
Gait deficit is a common and disabling symptom of MS. By supporting the brain’s ability to form new pathways, it may be able to compensate for the damage caused by MS. While this typically happens over a long period of time, the process of activating new and/or compensatory pathways in the brain can be promoted by utilizing neuromodulation techniques via a non-surgical device – this is where PoNS comes in.
The efficacy of PoNS Therapy has been assessed in 2 randomized clinical trials and 1 retrospective analysis involving patients with gait deficit due to mild to moderate symptoms from MS.
- The Tyler et al study suggests that individuals with MS using PoNS in conjunction with PT had improved gait scores over twice that of those using a sham device with PT.1
- The Leonard et al study suggests that PoNS stimulation can drive neuroplasticity to enhance gait motor performance.2
- A retrospective analysis of real-world treatment outcomes showed clinically and statistically significant improvements in functional gait assessment (FGA) with PoNS Therapy.3
To view the Real-World Evidence as presented at the 2022 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, click here.
HOW LONG IS PoNS THERAPY?
PoNS Therapy is a 14-week intensive physiotherapy program that combines in-clinic and at-home use of the PoNS device. The program is guided by a PoNS Trainer, focusing on balance, gait and breathing and awareness exercises.
CAN I COMPLETE SESSIONS OF PoNS THERAPY AT HOME?
The PoNS device is portable, which means PoNS Therapy can start in clinic and can be completed at home with check-ins from your PoNS Trainer.
CAN I USE PoNS ON MY OWN?
The PoNS device is only available with a prescription and to be used in conjunction with PT. The 14 week program is guided by a PoNS Trainer who will provide PT exercises targeted to your individual needs.
Visit our Find A Clinic page to locate a clinic offering PoNS Therapy near you.
DO I NEED A PRESCRIPTION FOR PoNS THERAPY?
Yes, talk with your doctor to see if PoNS Therapy is right for you. They can write a prescription for you and fax it to 1 (215) 754-4903.
DOES INSURANCE COVER PoNS THERAPY?
While PoNS Therapy is not currently contracted with government or commercial payers, PoNS has received HCPCS codes and a preliminary determination for reimbursement from the Centers for Medicare & Medicaid Services (CMS). We anticipate the final pricing determination in Q3, which will become effective on October 1, 2024.
We are actively engaging with commercial and private payers across the U.S. to secure coverage for PoNS. While we’re waiting for broad coverage, we are assisting in submitting claims for PoNS on a case-by-case basis. If you are interested in discussing your specific insurance coverage and potential reimbursement for PoNS, please contact us.
United States Veterans interested in obtaining PoNS, should reach out directly to Helius at 877.546-0008 or [email protected] to learn about coverage options.
More information can also be found at:
https://ponstherapy.com/for-patients/veterans/.
IS PoNS SAFE?
No serious adverse events related to the PoNS device were reported in the MS RCTs or have occurred during its use in clinical rehabilitation settings to treat balance and gait disorders.
Some individuals have reported headaches, fatigue, and excess salivation. Excess salivation during training sessions often occurs but generally improves as patients get used to wearing the mouthpiece.
ARE THERE ANY PoNS DEVICE CONTRAINDICATIONS OR PRECAUTIONS?
The PoNS® device delivers electrical stimulation directly to the surface of the tongue. Precautions for use are similar to those for transcutaneous electrical nerve stimulation (TENS).
Electrical stimulation should not be used:
- If there is an active or suspected malignant tumor
- In areas of recent bleeding or open wounds
- In areas that lack normal sensation
The PoNS® has not been tested on, and thus should not be used by individuals who are pregnant. Do not use the PoNS® if you are sensitive to nickel, gold or copper.
REFERENCES
- Tyler ME, Kaczmarek KA, Rust KL, Subbotin AM, Skinner KL, Danilov YP. Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial. J Neuroeng Rehabil. 2014;11:79.
- Leonard G, Lapierre Y, Chen J-K, Wardini R, Crane J, Ptito A. Noninvasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplastic changes in patients with multiple sclerosis: a multimodal neuroimaging study. Mult Scler J Exp Transl Clin. 2017;3(1):2055217317690561.
- Helius Medical, Inc. A Portable Neuromodulation Stimulator (PoNS) Real-World Evidence Study August 2, 2020.