Experimental Tongue Therapy Helps Restore Brain Function

[NHE]

Helius Medical wins FDA nod for tongue stimulator that improves MS patients’ gait
https://www.massdevice.com/helius-medic ... GJ65G-tZxg

I was informed yesterday
I was very surprised......
Wondering how they did that

There were two studies submitted to the FDA combined with treatment data from their Canadian clinics. One study had 20 patients, the other only had 14. Helius only needed to find 17 patients that responded to the PoNS treatment (assuming the studies were equally matched for the control and treatment groups). That's not very many considering the number of negative reports from MS patients' experience with the PoNS.

https://content.govdelivery.com/account ... ns/2c9b04c

The FDA assessed the safety and effectiveness of the PoNS device through two clinical studies and a retrospective analysis of real-world data (RWD). In the first study, 20 patients with gait deficits due to MS participated in a randomized, double blind controlled trial where 10 patients used the PoNS device and the remaining 10 patients used a sham control device that did not deliver stimulation. The primary outcome measure was the Dynamic Gait Index (DGI) where the clinician scored an index of eight gait tasks. The DGI was assessed for a baseline, at two weeks, six weeks, 10 weeks, and 14 weeks. The results showed that the PoNS group on average achieved improvement in their DGI score of 7.95 at the end of the study, which was statistically significant and clinically significant, while the control group did not.

In the second study, the clinicians investigated the effects of the PoNS device with cognitive rehab and physical rehab in 14 patients with MS, who did not know whether they had the PoNS device or the sham control device, in a randomized controlled trial where seven patients used the PoNS device and the other seven used a sham device. Baseline evaluations included sensory organization tasks (SOT) and DGI scores. The PoNS device group showed a statistically significant improvement in SOT scores at 14 weeks compared to the baseline value. Analysis of DGI scores after 14 weeks showed no significant result.

The sponsor also provided a retrospective analysis of RWD collected with the PoNS device in MS patients in clinical rehabilitation settings. Patients who agreed to treatment were given 1-hr consultation, provided consent, and given baseline assessments of gait function using Functional Gait Assessment. No serious safety adverse events were reported in the clinical studies or retrospective analysis of RWD.