Research Studies
The Studies Behind PoNS
Multiple Sclerosis
Leonard et al.1
Working memory and gait imagery activity during fMRIscans revealed brain activation in the dorsolateralprefrontal cortex, anterior cingulate cortex, and left motor cortex, after 14 weeks of PoNS therapy, while the control group only showed increased activation in premotor cortex from baseline.
*statistically significant change
Tyler et al2
100% improvement in the DGI* scores All 10 subjects in the active PoNS + PT group experienced at least a 4-point improvement from baseline to week 14 in the Dynamic Gait Index. Only 3 subjects in the Placebo PoNS + PT group experienced at least a 4-point improvement from baseline to week 14 in the Dynamic Gait Index.
*DGI = Dynamic Gait Index, a measure of the ability to walk. Tyler et al. Journal of NeuroEngineering and Rehabilitation 2014, 11:79
PoNSTEP
Adherence (≥71%) to PoNS treatment is associated witha statistically significant and clinically meaningful improvementin gait deficit over 14 weeks. Participants with ≥85% adherence were fall risk free (60%) and maintained improvement at 6-mafter end of treatment.
Stroke
Stroke Registrational Program
Treatment with PoNS transitions standard physical rehabilitation therapy from a non-clinically significant (PT) to a clinically significant outcome (PoNS + PT). PoNS Therapy led to a clinically meaningful (MCID >4) adjusted mean change in FGA of 5.37 points (95% CI: 4.23 to 6.52) from baseline to Week 12, while the sham group experienced a non-clinically meaningful changeof 3.31 points (95% CI: 1.96 to 4.66).
Responder Rate
45% more subjects achieved a Clinically Meaningful (CM) response in the PoNS group using a 6-point threshold (56.1% vs 11.1%) and at least 30% more subjects achieved response in the PoNS group at a ≥4-point improvement threshold (63.1% vs 33.3%) than in the sham group.
*statistically significant change
Real World Evidence
In all clinical studies and the real-world utilization, no one experienced any serious or persistent side effects associated with the device.
Contact us to learn more about PoNS.
- Leonard et al. (2017); Multiple Sclerosis Journal – Experimental, Translational and Clinical
- Tyler et al. (2014); Journal of NeuroEngineering and Rehabilitation
- Favit-VanPelt (2022); CMSC Poster
- Helius Medical Inc. (2023); Statistical Analysis Report (Data on file, January 26, 2023)
Indications for Use: 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. The PoNS device is indicated for use as a treatment of dynamic gait deficits due to chronic symptoms from stroke and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
The PoNS device delivers electrical stimulation directly to the surface of the tongue. Precautions for use are similar to those for wearable electrical stimulation medical devices. Electrical stimulation should not be used: if there is an active or suspected malignant tumor, in areas of recent bleeding or open wounds, and 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.
Full prescribing information can be found in product labeling or at: www.bionessmedical.com/pons/safety-information.
Instructions for Use / Patient Guides can be made available upon request.
Contact [email protected] or 855-902-5252 to request an electronic copy.
