This Is MS Multiple Sclerosis Knowledge & Support Community

2020 Sep 3
Department of Medicine, University of Toronto
A Review of the Evidence and Current Applications of Portable Translingual Neurostimulation Technology
https://pubmed.ncbi.nlm.nih.gov/32881193/


Abstract

Objectives: Translingual neurostimulation (TLNS) with adjunct physical rehabilitation is used to treat balance and gait deficits in several chronic neurological conditions. The purpose of this review is to summarize and appraise the evidence currently available on the portable TLNS device and to assess its potential clinical application.

Materials and methods: In this narrative review, MEDLINE, EMBASE, Web of Science, and Google Scholar were searched for primary research investigating the use of portable TLNS devices on any neurologic condition. Data were extracted, reviewed, and appraised with respect to study design, conduct, and reporting.

Results: Five randomized controlled trials (RCTs), three quasi-experimental trials, and seven case reports/series were found. Most studies demonstrated improvements in balance and gait deficits secondary to traumatic brain injury and multiple sclerosis, but evidence is also present to a lesser degree for stroke and balance disorder patients. In these studies, the feasibility and safety of TLNS have been convincingly demonstrated. Functional magnetic resonance studies have also suggested a plausible neuroplastic therapeutic mechanism. However, the efficacy of TLNS remains unclear due to bias and confounding within studies, and heterogeneity of results between studies.

Conclusions: TLNS is a promising treatment modality for various chronic neurological conditions that are often refractory to conventional therapy. However, TLNS technology remains largely investigational as high-quality RCTs are still required to elucidate efficacy, optimal dosages, necessary treatment durations, and treatment durability. Further research to develop an appropriate control group is needed for scientifically valid comparisons of TLNS.

Keywords: Brain injury; cranial nerve stimulation; high-frequency electrical stimulation; low-frequency electrical stimulation; multiple sclerosis (MS); neurostimulation; rehabilitation; stroke.

2023 Jun 9
BrainNet, Faculty of Applied Sciences, Simon Fraser University, Vancouver, BC, Canada
Real world evidence of improved attention and cognition during physical therapy paired with neuromodulation: a brain vital signs study
https://pubmed.ncbi.nlm.nih.gov/37362950/

Abstract

Background: Non-invasive neuromodulation using translingual neurostimulation (TLNS) has been shown to advance rehabilitation outcomes, particularly when paired with physical therapy (PT). Together with motor gains, patient-reported observations of incidental improvements in cognitive function have been noted. Both studies in healthy individuals and case reports in clinical populations have linked TLNS to improvements in attention-related cognitive processes. We investigated if the use of combined TLNS/PT would translate to changes in objective neurophysiological cognitive measures in a real-world clinical sample of patients from two separate rehabilitation clinics.

Methods: Brain vital signs were derived from event-related potentials (ERPs), specifically auditory sensation (N100), basic attention (P300), and cognitive processing (N400). Additional analyses explored the attention-related N200 response given prior evidence of attention effects from TLNS/PT. The real-world patient sample included a diverse clinical group spanning from mild-to-moderate traumatic brain injury (TBI), stroke, Multiple Sclerosis (MS), Parkinson's Disease (PD), and other neurological conditions. Patient data were also acquired from a standard clinical measure of cognition for comparison.

Results: Results showed significant N100 variation between baseline and endpoint following TLNS/PT treatment, with further examination showing condition-specific significant improvements in attention processing (i.e., N100 and N200). Additionally, CogBAT composite scores increased significantly from baseline to endpoint.

Discussion: The current study highlighted real-world neuromodulation improvements in neurophysiological correlates of attention. Overall, the real-world findings support the concept of neuromodulation-related improvements extending beyond physical therapy to include potential attention benefits for cognitive rehabilitation.

I may be wrong, but I’m not going to hold my breath about this treatment. The full article is available for free. It discusses the PoNS device by Helius Medical Technologies. This device has been discussed extensively at ThisIsMS. You may wish to read some of the latter posts in the topic.

viewtopic.php?p=258215#p258215

Helius’ stock traded under $1 for almost a year. It then underwent a 1:35 reverse split. This brought the share price up to about $11. It’s now been under $1 again for the last 10 months and is currently trading at $0.17. Another reverse split is imminent. If the PoNS was changing people’s lives, then I suspect that we would be seeing a very different scenario at this time especially after almost 4 years.

Petr75 wrote: ↑Tue Jun 27, 2023 9:42 pm Real world evidence of improved attention and cognition during physical therapy paired with neuromodulation: a brain vital signs study
https://pubmed.ncbi.nlm.nih.gov/37362950/

This research utilized a paired t-test experimental design. This compares the same group of patients to themselves before and after they received the 14 week PoNS therapy. There is no control group. This type of experimental design doesn’t isolate the effects from physical therapy (PT) from any benefit that may or may not result from using the PoNS device.

The paired t-test is an invalid statistical analysis for Helius' experimental design. Helius has changed two variables, PT and PoNS stimulation. However, the paired t-test lumps both treatment effects together and doesn't distinguish between the two. The use of an incorrect statistical analysis prohibits drawing any conclusions from Helius' studies and invalidates their conclusions.

Moreover, It’s well documented that physical exercise alone is good for the brain and increases BDNF. Here’s a 7 page topic discussing the benefits of exercise in MS including BDNF. It’s one of several such topics.

viewtopic.php?t=30674

Helius needs to do a placebo controlled trial comparing PT with the PoNS vs PT without the PoNS. However, I suspect that Helius will never do this. It might be the death of their company. Helius tried this back around 2018. Both the control and treatment groups used the PoNS. However, the control group’s setting was set so low it was thought to be ineffective. The control group was identical to the PoNS group (P=0.99). They tried to do a post-hoc analysis of the data redefining their experimental design and changing the primary endpoint of the study. The FDA didn’t buy it. The PoNS was rejected as a medical device. Helius’ share price crashed from about $8.25 to $2. It never recovered. They then issued the 1:35 reverse split. The stock plummeted once again. As discussed above, a reverse split is once again imminent.

As predicted, Helius Medical’s stock underwent a reverse split on August 17, 2023. The magnitude of the reverse split was 1:50! In response to the reverse split the stock’s share price has already fallen $1.95 from $9.82 to $7.87.

https://finance.yahoo.com/news/helius-m ... 00309.html

At $0.975/share Helius Medical's stock (HSDT) is, for the third time, less than $1.00/share. This does not bode well for Helius.

https://www.cnn.com/markets/stocks/HSDT

Helius has issued yet another reverse split. Effective May 1, 2025 at 5 PM ET, Helius' stock underwent a 1:15 reverse split. This was their 4th reverse split. These are 1:4, 1:35, 1:50 and 1:15. The splits represent a share reduction factor of 105,000x. This history does not bode well for Helius.

https://ir.heliusmedical.com/news-relea ... ck-split-0