FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

 

Will your competent? doctor and hospital be DOING ANYTHING WITH THIS?

Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING? Your choice; let them be incompetent or demand action!

FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

Bioness’s PoNS system is designed to improve gait impairment in stroke patients by stimulating the trigeminal and facial cranial nerves.

Bioness Medical’s oral neuromodulation system for rehabilitating stroke patients with gait deficits has secured clearance from the US Food and Drug Administration (FDA). The California-based company’s portable neuromodulation stimulator (PoNS) system delivers neurostimulation through a mouthpiece placed on the tongue. Designed for at-home use in conjunction with physical rehabilitation, the prescription-only device stimulates branches of the trigeminal and facial cranial nerves, activating direct connections to the brainstem. This treatment approach promotes the development of new neural networks to compensate for impaired corticospinal pathways, with the aim of improving walking function in individuals following a stroke, Bioness stated. The device’s clearance for stroke rehabilitation was supported by Bioness’s three-study Stroke Registrational Program (SRP) that evaluated PoNS’ safety and efficacy in conjunction with physical rehabilitation therapy as compared to physical therapy (PT) alone over a 12-week treatment period. Bioness acquired the PoNS system product line from original developer Solana Company (formerly known as Helius Medical Technologies) in April 2026. Prior to the transaction, for which financial terms were not publicly disclosed, PoNS held an FDA indication for multiple sclerosis (MS) treatment.&mThe 159-patient SRP met its primary endpoint, with statistically significant improvements on the Functional Gait Assessment (FGA) scale. Treatment with PoNS plus PT led to an adjusted mean change in FGA of 5.37 points at week 12, versus a non-clinically meaningful change of 3.31 points in the control group. Meanwhile, 45% more subjects treated with PoNS responded to treatment on the basis of a six-point FGA increase threshold, with at least 30% more on the basis of a ≥4-point or ≥5-point improvement threshold. Bioness’ CMO, Antonella Favit-Van Pelt, commented: “The totality of data in chronic stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by transitioning the outcome of physical therapy alone to a clinically meaningful effect with a 45.5% increased response rate to PoNS treatment as compared to PT alone.”

Neuromodulation is having a significant impact in the healthcare space for the treatment of conditions ranging from sleep apnoea and chronic migraine to major depressive disorder (MDD). According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of over $13bn in 2035, up from around $6.8bn in 2025.

Retroflex tongue as a non-invasive neurological marker of functional severity in older adults with ischemic stroke: a retrospective observational study

NOTHING IN THIS MEASUREMENT GETS YOU RECOVERED! USELESS!

 Retroflex tongue as a non-invasive neurological marker of functional severity in older adults with ischemic stroke: a retrospective observational study

Yung-Sheng Huang^1,2Hen-Hong Chang^3,4,5John Y. Chiang^6,7Po-Chi Hsu^5,8*Lun-Chien Lo^2,5,8*

• ¹Graduate Institute of Chinese Medicine, China Medical University, Taichung, Taiwan
• ²Department of Traditional Chinese Medicine, Changhua Christian Hospital, Changhua, Taiwan
• ³Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan
• ⁴Chinese Medicine Research Center, China Medical University, Taichung, Taiwan
• ⁵Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan
• ⁶Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung, Taiwan
• ⁷Department of Computer Science and Engineering, National Sun Yat-sen University, Kaohsiung, Taiwan
• ⁸School of Chinese Medicine, China Medical University, Taichung, Taiwan

Background: With the growing global burden of ischemic stroke in aging populations, there is increasing interest in simple and non-invasive neurological markers to support early risk stratification and functional prognosis. Retroflex tongue (RT) and tongue deviation (TD) are observable signs of cranial nerve dysfunction; however, their comparative predictive value for stroke severity remains unclear.

Methods: In this retrospective observational study, 308 older adults (mean age: 69.1 years) hospitalized with ischemic stroke were enrolled. Tongue motor function was evaluated using an automatic tongue diagnosis system (ATDS). Deviation angles were measured, and the presence or absence of RT was assessed by trained traditional Chinese medicine physicians. Stroke severity and functional outcomes were evaluated using the National Institutes of Health Stroke Scale (NIHSS), Barthel Index, and length of hospital stay.

Results: Among the 308 patients, 59 (19.2%) exhibited TD and 249 (80.8%) did not. No significant differences were found in baseline characteristics between TD groups, except for deviation angle (TD: 9.72° ± 8.91° vs. non-TD: 6.40° ± 7.84°, p = 0.011). Patients without RT had significantly worse clinical outcomes, including longer hospital stays (32.0 vs. 25.9 days, p = 0.007), higher NIHSS scores (14.1 vs. 8.9, p < 0.001), and lower Barthel Index scores (18.6 vs. 35.0, p < 0.001), compared to those with RT. In contrast, TD showed no significant association with these outcomes. Multivariate regression identified non-RT as an independent predictor of stroke severity. ROC analysis supported the discriminative value of RT (AUC = 0.703 for NIHSS ≥ 9; AUC = 0.712 for Barthel ≤ 17), whereas TD showed poor predictive ability (AUC = 0.524 and 0.570, respectively).

Conclusion: Absence of retroflex tongue is more strongly associated with stroke severity and functional impairment than tongue deviation. As a simple, observable motor sign, RT may serve as a practical bedside indicator for early neurological assessment. However, given its preliminary status, further validation in prospective, multi-center studies is warranted before clinical application.

New hope for stroke patients: University of Cincinnati trial tests unique tongue exercise device

How long before your competent? hospital reaches out to these researchers to see what the protocol is and where the device can be purchased? Do you even have a functioning stroke hospital? If they don't have a research analyst following and implementing stroke research, then you don't have a useful stroke hospital! They are a dinosaur living in the past waiting for that meteorite to obliterate them.

New hope for stroke patients: University of Cincinnati trial tests unique tongue exercise device

Up to three-quarters of all stroke survivors experience some form of difficulty swallowing (dysphagia). This condition often results in food or liquid entering the lungs, significantly affecting patients' health and quality of life.

Image Credit: ARENA Creative/Shutterstock.com

In extreme cases, dysphagia can lead to an inability to eat or drink or even death from aspiration pneumonia. The social aspect of eating and drinking being hindered, dysphagia can also contribute to depression in patients.

The Gardner Neuroscience Institute, supported by a $660,000 NIH grant, is launching a trial to test an at-home tongue endurance exercise aimed at improving swallowing function in stroke survivors.

Brittany Krekeler, PhD, Speech language pathologist and trial principal investigator, describes swallowing issues as a "hidden" disorder often overshadowed by primary diseases.

Krekeler emphasizes the emotional and physical burden of dysphagia on patients and their families, noting the significance of being able to eat and drink normally.

Historically addressed through feeding tubes, dysphagia research is now exploring more effective treatments, moving away from a one-size-fits-all approach to more personalized therapies.(Protocols can be properly written to cover different variations in the problem.)

Treating dysphagia is like an artform, so depending on what therapist you go to, you’ll get a different approach,” Krekeler said. “Current treatment approaches are really a mixed bag depending on what institution you’re at and what therapist you’re seeing.” (So incompetence  reigns! No one has written a protocol on recovering from this!)

About the trial

Unlike traditional therapies that emphasize total tongue strength, this trial will concentrate on improving tongue endurance, akin to repetitive, sub-maximal movements during eating.

The study will enroll patients who are 3-6 months post-stroke, a time of heightened neuroplasticity, offering a window for potentially more effective rehabilitation.

Participants will use a Bluetooth-connected device to perform tongue exercises, receiving real-time feedback. The exercises are designed to increase in difficulty over an eight-week period. The trial will also include MRI studies to observe brain changes related to learning the new tongue exercises.

We think that learning how to use the device might actually be part of the therapy, and in our field, we haven’t really looked at the learning curve in terms of using your tongue to do something new,” Krekeler said. “To investigate this potential learning effect, we’re also doing MRIs on a small subset to see what changes occur in the brain with learning how to use a tongue device.”

Potential for wider impact

While the study initially focuses on stroke patients, the insights gained could benefit individuals with swallowing issues due to other conditions like head and neck cancer and Parkinson's disease.

The trial represents a step towards determining the most effective combination of interventions for recovering swallowing function.

Brittany Krekeler received this prestigious grant, indicating her promise as a future independent researcher in the field.

The trial benefits from the mentorship of established researchers in stroke research and biostatistics, providing Krekeler with valuable guidance and support in conducting effective stroke trials.

For information on enrolling in the trial, please contact the trial’s research coordinator, Anna Hopkins, by emailing hopkiak@ucmail.uc.edu.

Source:

• https://www.uc.edu/news/articles/2023/12/uc-trial-tests-tongue-exercises-to-improve-swallowing-after-stroke.html

WVXU: UC study tests tongue exercises to improve swallowing function after stroke

In case you need this and your doctor is not up-to-date.

WVXU: UC study tests tongue exercises to improve swallowing function after stroke

WVXU highlighted a new trial at the University of Cincinnati that will test an at-home tongue endurance exercise to improve patients’ swallowing function after a stroke. 

Up to three-quarters of all stroke survivors have some form of difficulty swallowing (dysphagia) after a stroke.

"When you have a stroke, or another condition that impairs your swallowing, it impacts your life in an incredible way," Brittany Krekeler, PhD, assistant professor and clinician-scientist at the UC College of Medicine’s Dysphagia Rehabilitation Laboratory, told WVXU.

The study will enroll patients who have trouble swallowing three to six months after their stroke. Patients enrolled in the study will receive a device with a pressurized bulb that connects to their phone or tablet through Bluetooth to give them real-time feedback about how hard they are pressing the bulb with their tongue.

Participants in the trial will press their tongue to the bulb, with the device recording the number of times they do so and if they meet their goal. They’ll complete the exercises three times a day for eight weeks, with their goal increasing as they build endurance. 

"We're trying to target fatigue resistance or endurance of the tongue instead of strength because to swallow, you don't have to push your tongue as hard as you can every single time, you have to generate enough pressure to move whatever is in your mouth through your throat into your esophagus," Krekeler said. "What we're doing in this study is training people to press repeatedly over a longer period of time with the hope that that will carry over to more functional swallowing change."

Read the WVXU story.

Read more about the research.

Featured photo at top of a patient working in the Dysphagia Rehabilitation Laboratory. Photo/Rachel Treinen Photography.

Improving Upper Extremity Function and Quality of Life with a Tongue Driven Exoskeleton: A Pilot Study Quantifying Stroke Rehabilitation

  You'll have to send your doctor after this if you think it might help you. 

Improving Upper Extremity Function and Quality of Life with a Tongue Driven Exoskeleton: A Pilot Study Quantifying Stroke Rehabilitation