For general inquiries, call 1 877-564-0008 or [email protected]. Fax PoNS device prescriptions to 1 (215) 754-4903.

Impactful therapeutic outcomes

Functional Outcomes of PoNS Therapy®

Gait deficit results from impairment of neural mechanisms that deliver the signal to, and through, the spinal cord. Physical therapy is known to provide therapeutic benefits to MS patients with gait impairment. However, physical therapy alone may not be enough to provide a long-term functional improvement.

As observed in PoNS® clinical trials, the potential neuromodulation effect of physical therapy, observed in the sham group and showing increased activity in the bilateral premotor cortex areas from baseline, may be responsible for a short-term clinically meaningful improvement in gait. However, since physical therapy alone is not likely to induce neuroplastic effects, this may contribute to a decline of function over the treatment period.

brain graphic
Neuromodulation
Adaptive Changes
Consolidated Neuroplasticity

Consolidation of compensatory processes resulting from engaging neuroplasticity mechanisms by daily treatment, may be responsible for promoting functional improvement (peaking at week 10) and maintaining it through the end of the treatment period (14 weeks).

Clinical Benefits and Real-World Evidence

Real world data consolidate the evidence on clinical benefits and therapeutic outcomes with 14 weeks of PoNS Therapy in individuals with gait and balance deficit. A retrospective analysis of RWE effectiveness data demonstrated clinically and statistically significant improvements in gait for individuals with MS using PoNS as reflected by improved FGA total scores. 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.

Click here to view the RWE Poster Presentation. Healthcare providers interested in additional medical/scientific information about PoNS® can submit a Medical Information Request Form. A Medical Affairs representative will respond within 24 hours to provide the requested information.

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.
Danilov Y, Skinner K, Tyler M (2015). Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. CRC Press/Taylor & Francis.

IMPORTANT SAFETY INFORMATION

No serious adverse events related to the PoNS device were reported in the MS RCTs or in 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.

Indication
The PoNS® device is indicated for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis and is to be used as an adjunct to a supervised therapeutic exercise program for adults 22 years of age and over by prescription only.

Contraindications
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.

Use with caution
Electrical stimulation should only be used after seeking professional medical advice, and with caution in patients with any of the following:

  • Implanted electronic devices, including:
    • Cardiac pacemakers
    • Cardioverter defibrillators
    • Deep Brain Stimulators
    • Vagal Nerve Stimulators
    • Sacral nerve stimulators
    • Cochlear Implants
  • Metal in the mouth (e.g. piercings, braces, retainers, or other orthodontic appliance)
  • Seizure disorders
  • Epilepsy

Ready to get started with PoNS?

Patients who are seeking more information on how to get PoNS can email us at [email protected], or fill out our contact form: